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Das Execruit-Team bringt ein unvergleichbares professionelles Engagement mit, um Ihre Anforderungen in den Bereichen Talent-Rekrutierung, Führungsentwicklung & Beurteilung, Karriereentwicklung, Outplacement und E-Learning zu erfüllen.

Key responsibilities:

  • Following clearly defined briefs from our clients, your focus is to drive diligent filtering of applications, reviewing CVs, vetting candidates, interviewing and evaluating their experiences and skills – with the ultimate goal of developing strong short-lists of candidates for our clients.
  • Recruiting for executive, yet technically complex roles, is both a demanding and a rewarding experience. Our customers have high expectations and so do the prospective candidates.. Therefore, the need to be proficient about the industry and the target roles’ specifics are essential for success in this role.
  • This role is perfect for someone who is intellectually stimulated by complex and challenging missions, and sufficiently curious to make “finding a needle in haystack’ motivating.
  • There is a wealth of well-established tools and deployable approaches available to your disposal, in order to succeed in the role, internally and externally.
  • Your major deliverable on every initiative is a well-motivated and well-documented short-list of stellar candidate profiles.

Your profile:

  • Demonstrated ability to productively engage and communicate with various audiences
  • Strategic, analytical and methodical in approach to tasks
  • 3+ years of recruitment experience in Life Sciences (ideally for global roles)
  • Industry specific knowledge in healthcare technology (some subject matter expertise)
  • Excellent written and verbal communication skills
  • Driving for and achieving results in complex environment
  • Self-drive (initiative) combined with open partnership and support seeking behaviours

Job Features

Job CategoryHR SERVICES

Key responsibilities: Following clearly defined briefs from our clients, your focus is to drive diligent filtering of applications, reviewing CVs, vetting candidates, interviewing and evaluating their...

Posted 3 months ago

Key responsibilities:

  • Leads and facilitates cross-functional interfaces and interactions within the Clinical Trial Team and external partners (i.e., CRO and other vendors)
  • Provides direct input to protocol development and other essential trial-level documents to ensure efficient and effective delivery of trial objectives and in accordance with the relevant Standard Operating Procedures
  • Develops, executes, and maintains operational Risk Management Plan highlighting potential risks and actions
  • Creates and drives trial level milestones and timelines. Oversees trial level performance against the agreed plans (including global recruitment and projection plan), milestones and key performance indicators
  • Ensures all trial-related documents and systems (e.g., clinical database, IRT etc.) required for Ethics/Regulatory submissions and trial initiation are developed by the Clinical Trial Team and CRO/vendors within the specified timelines
  • Ensures selection of clinical trial sites which meet protocol requirements, and all essential documents are in place for approval of site initiation and release of Investigational Medicinal Products to the sites
  • Ensures CRO/vendors contracted at trial level are performing to contractual obligations and timelines/budget and that oversight is documented and any issues are escalated appropriately
  • Responsible for trial budget, reforecasting after initial budget estimate and for management through the trial lifecycle and provide budget process report including any financial risks and mitigation plans
  • Ensures clinical trial is inspection-ready at all time and Trial Master File (TMF) completion including TMF plan is in place and ongoing QC activities are performed to always ensure TMP completeness

Your profile

  • Bachelor’s Degree/Master’s Degree in Science or Healthcare
  • 5-8 years of relevant clinical experience in pharmaceutical industry including 2-3 years of project management experience
  • Excellent knowledge of Good Clinical Practice, regulatory process, and clinical development process
  • Experience with health authority inspections (FDA/EMA) and audits preferred
  • Strong critical thinking and problem-solving skills
  • Strong team leadership and project management skills with ability to collaborate across function in a matrix environment
  • Excellent communication, interpersonal and conflict management skills with ability in establishing and maintaining effective working relationships with internal and external team members and stakeholders
  • Ability to work under pressure and managing competing priorities
  • Demonstrated ability to effectively forecast and manage trial budget
  • Fluent in English (French and another European language are an asset)

Job Features

Job CategoryCLINICAL OPERATIONS

Leads and facilitates cross-functional interfaces and interactions within the Clinical Trial Team and external partners (i.e., CRO and other vendors)

Key responsibilities:

  • Serves as a core member of Core Team and Sub-team(s) representing Global Clinical Operations and contributes to the development of the Clinical Development Plan of the assigned program/indication
  • Conducts program level planning of the assigned program/indication to establish global resource requirements and high-level recruitment strategies
  • Accountable for the operational delivery (including risk management and mitigation) of the assigned program/indication and associated clinical trials and for all related strategic planning, prioritization of activities, within the program
  • Partners with the Medical Director and other Core Team members, actively offers operational insights and options to contribute to the program/indication and clinical trial strategy, with respect to clinical trial design and protocol optimization and timelines planning
  • Leads the Clinical Trial Teams in the execution of clinical trials and oversee the progress and deliverables (including trial budget and spending)
  • Provides guidance to Clinical Trial Teams during the development of the trial execution plan, managing trial budgetary issues, resolving trial issues, and implementing appropriate measures
  • Monitors Clinical Trial Teams and CRO/vendor performance through KPIs, and work with the appropriate Development Functional Leaders to optimize Clinical Trial Teams and CRO/vendor performance
  • Point of contact for escalation and resolution of trial related issues. Participates in vendor governance meetings to monitor and address performance issues and escalation/resolution of issues encountered by the Clinical Trial Teams
  • Provides oversight on operational quality and compliance in conjunction with Quality Assurance
  • Supervises Clinical Trial Teams in inspection readiness activities and attend Health Authority inspections to manage and answer/coordinates responses to inspection requests
  • Contributes and provides operational input into the due diligence activities
  • Authors/reviews Standard Operating Procedures (SOPs) for the conduct of clinical trial and acts as a Subject Matter Expert for training or SOPs
  • Participates in Clinical Operations Meetings and/or cross-functional forums to exchange information, best practices, and issues

Your profile

  • Bachelor’s Degree/Master’s Degree/PhD in Science or Healthcare
  • 8 years or more years of experience in pharmaceutical drug development with management in a matrix organization
  • Experience with FDA or EMEA inspections including sponsor GCP inspections
  • Strong team leadership with ability to manage multiple individuals and teams simultaneously
  • Strong problem-solving skills with ability to resolve issues with minimal supervision and understand when to escalate
  • Strong interpersonal skills with ability to effectively communicate, interact and work with individuals and teams and to bridge cross-functional stakeholder (business, scientific and technical)
  • Performance driven with ability to deliver results and fast in implementation
  • Strong knowledge of therapeutic area and fully knowledgeable in area of responsibility serving as source of expertise for others
  • Strong knowledge of clinical development processes and understanding roles and responsibilities of Clinical Trial Team members to drive execution of clinical development program
  • Strong knowledge in clinical trial forecasting, budgeting, and contracting
  • Fluent in English (French and another European language are an asset)

Job Features

Job CategoryCLINICAL OPERATIONS

Serves as a core member of Core Team and Sub-team(s) representing Global Clinical Operations and contributes to the development of the Clinical Development Plan of the assigned program/indication

Posted 4 months ago

Key responsibilities:

  • Lead the development and implementation of the site R&D strategy including alignment with the site objectives and Global R&D
  • Responsibility for leading the development, scale-up, registration/validation of drug substance, particle engineering and drug development programs for the site
  • Promote the scientific excellence and innovation in the area and contribute with technical expertise to expand the Intellectual Property, product and technology portfolios.
  • Establish the main objectives for the area, aligning these with R&D and company’s corporate strategy
  • Establish a clear site R&D strategy including resources, capital investment, new technologies etc in order to meet customer and business needs
  • Ensure the development of safe, efficient, scalable, timely and cost-effective processes of commercial interest to the company
  • Identify and assess new business opportunities, trends and market needs, in collaboration with commercial colleagues, and ensure the use of up to date / best technology, processes and work practices
  • Facilitate and manage a culture of innovation within the group focused upon creating new technology value and solving existing technical challenges in alignment with the global R&D strategy
  • Develop and manage metrics designed to monitor performance and improves efficiencies, quality and HSE culture within the area
  • Devise and coordinate the implementation of new procedures or the change of existing ones, according to ruling COPs, SOPs and IOPs
  • Represent the R&D area (or nominate delegates) on meetings with clients, external and internal audits and for Product/Project teams.
  • Ensure the information flows between the R&D areas, the several internal and external customers and stakeholders
  • Promote scientific activities (i.e. seminars, congress participations, innovation ideas, papers and publications), innovation and implementation of new methodologies within the R&D area
  • Manage the R&D team including recruitment, integration, training needs and performance management in accordance with the company's HR policies and ensuring the team is aligned and motivated towards achieving company's goals.
  • Develop and propose for approval the short and mid-term goals, annual budget and budget plan in line with the corporate strategy, in order to align activities with company's strategic objectives.
  • Prepare and propose the annual area budget for the annual site R&D budget.
  • Ensure compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others).

Your profile:

  • PhD or Masters’ degree in one of the following areas Chemistry, Chemical Engineering, Materials Sciences or related field.
  • Minimum 8 - 10 years of relevant experience in Research & Development or Manufacturing Sciences in the Pharmaceutical Industry
  • Demonstrated track record in building R&D capabilities, ideally within in a CDMO environment
  • Client relationship experience
  • Possess extensive knowledge of Heat Transfer, Scale-up, Process Safety and Industrial Operations, or of drug product unit operations, solids flow phenomena and process equipment principals and practices, and is able to lead others on them
  • Good communication skills (verbal and written)
  • Skilled at driving processes and tools
  • Fluency in English is a requirement
  • Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.

Job Features

Job CategoryTECHNICAL R&D

Lead the development and implementation of the site R&D strategy including alignment with the site objectives and Global R&D. Responsibility for leading the development, scale-up, registration/valida...

Posted 9 months ago
Key responsibilities:
  • Audit & CAPA process owner
  • On behalf of the Head of Quality, act as business owner for “Audit & CAPA System”: single point of contact to adequately support the Quality & Business representatives with regards to system related questions.
  • Ensure the risk-based audit strategy is properly applied, in close collaboration with the GxP Quality Leads and the Business Partners.
  • Create & maintain global GxP audit programs (in line with business priorities and timelines) materialized by means of a Master Audit Plan.
  • In line with the outsourced audit model, select qualified auditors to timely execute the agreed Master Audit Plan covering 3rd parties, systems, processes, studies, documents, etc… to adequately assess compliance with DPI Procedural Documents and applicable regulations.
  • Manage all audit activities starting from audit planning, preparing, execution up to delivering final report.
  • Contribute to preparation and conduct activities of Regulatory Authority Inspections.
  • Work with GxP Quality Lead in view of adequate and timely CAPA development.
  • Oversee / Manage Quality Coordinator to populate the Audit / CAPA system as per Audit / CAPA process requirements.
  • Develop meaningful Audit / CAPA metrics allowing proper oversight / follow-up by business representatives (owners & department heads).
  • Generate Audit / CAPA metrics to indicate areas for improvement and to drive continuous improvement initiatives.
Your profile:
  • University degree: Pharmacist Diploma, PhD, master’s in science
  • 5 to 8 years’ experience in managing quality assurance within the pharmaceutical industry and/or Biotech companies
  • Minimum 3 years’ experience with GxP Audits
  • Minimum 3 years ‘experience in managing tracking systems such as CAPAs database resulting from GxP audits (ex for GCP: CROs, TMF, Investigational Sites and CSR) as well as deviations, changes tracking systems
  • Solid knowledge of GxP
  • Good practical experience in using validated electronic quality systems tools (TrackWise, Veeva, Ennov, etc)
  • Knowledge of computerized systems validation
  • Rigor, flexibility, adaptability, and organization
  • Pragmatism focused on efficiency and continuous improvement
  • Capacity to think strategically and to keep an overall view while bringing efficiency to daily detailed activities

Job Features

Job CategoryLIFE SCIENCES, QUALITY ASSURANCE/COMPLIANCE

Key responsibilities: Audit & CAPA process owner On behalf of the Head of Quality, act as business owner for “Audit & CAPA System”: single point of contact to adequately support the Qualit...

Key responsibilities:

  • Drive development of protocols/protocol amendments for clinical studies
  • Prepare and/or provide input to clinical study related and other regulatory documents (e.g. CSRs, IBs, PIS/ICFs, SAPs, Data Management Plans, Safety Management Plan, Medical Monitoring Plan, SRC Charter, IND, briefing books)
  • Work closely with clinical team members within the assigned project to execute activities associated with the conduct of clinical trial
  • Contribute to development of end-to-end clinical development strategy
  • Prepare and/or provide input to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
  • Monitor, review and interpret safety and efficacy data of ongoing clinical trials
  • Act as (clinical science expert) liaison to cross-functional project core team, clinical study teams, CRO's, study sites and others
  • Establish relationships with investigators, KOLs, partners and appropriate consultants
  • Provide clinical scientific input to business development (e.g. due diligence) and marketing activities
  • Perform literature research
  • Develop and deliver presentations to internal and external stakeholders. Provide input in scientific communication plan and scientific publications
Your profile:
  • Master's in Life Sciences, Pharmacist or PhD in Life Sciences (preferred)
  • At least 7-10 years of relevant experience in clinical development within the pharmaceutical industry, including development of CDPs and protocols
  • Experience in conducting Clinical Studies in Oncology
  • Experience in Prostate Cancer
  • First experience working on studies in Anti-infectives in an asset
  • Broad experience in the principles and techniques of data review, analysis, signal detection, interpretation and clinical relevance
  • Well-versed in medical aspects of GCP, ICH, FDA, EMEA and other relevant guidelines and regulations
  • knowledge of the multidisciplinary functions involved in drug development process (e.g.: clinical operations, biostatistics, regulatory, business, etc.) and can proactively integrate multiple perspectives into the clinical development process for best end-results.
  • Driven and proven abilities to perform responsibilities independently and with limited guidance
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget delivery. Focused on results, flexible and open-minded, able to adjust to changing circumstances.
  • Strong interpersonal, verbal/written communication, negotiation and influencing skills in English
  • Proven track record of effective decision-making: makes good business decisions and exercises sound judgment
  • Proven teamwork skills: has a proven track record of working highly effectively, efficiently and collaboratively with multidisciplinary teams. Demonstrate curiosity and challenge status-quo

Job Features

Job CategoryCLINICAL DEVELOPMENT

Drive development of protocols/protocol amendments for clinical studies. Prepare and/or provide input to clinical study related and other regulatory documents (e.g. CSRs, IBs, PIS/ICFs, SAPs, Data Man...

Key responsibilities:

Clinical development strategy

  • Provides the strategic direction and clinical development plans (definition and updates).
  • Is a permanent member of Core team, leader of the clinical sub-team and depending on the program, may also be a member of study team.
  • Provide medical/clinical expertise to Core Team to support the development and Launch of the product.
  • Assist the Program Leader for drawing up the project strategy, including the search of new indications.
  • Is responsible for clinical input in both internal and regulatory project documents
  • Contribute to the review of available data and competitive environment for the product(s). Maintain up to date awareness of all-important advances within a given disease area through scientific literature, attendance at critical meetings and relationships with Key Opinion Leaders (KOLs).
  • Establish and maintain communications with prominent clinical investigators in field of expertise. Liaise with internal and external medical community to follow developments within area of expertise.
  • Set-up and manage Advisory Boards.
  • Frequent involvement in Business Development activities.
  • Represent the company clinical perspective in meetings with partners. Involvement on due diligence activities.
  • Contributor to portfolio decisions.

Develop clinical trial protocol

  • Develop a well thought, and medically solid clinical trial synopsis aligned with the clinical development strategy.
  • Develops medical content for protocol and amendments.
  • Support clinical operations team to the selection of investigators/sites to run clinical trials.
  • Support regulatory team for successful submission of protocol to regulatory authorities.

Medical monitoring of clinical trials

  • Serve as a trial level physician and medical monitor for clinical studies.
  • Leads dose-escalation meetings.
  • Reviews emerging clinical data regularly.
  • Managing and oversee the medical monitoring teams of CROs.
  • Provide consultation to clinical operation colleagues on protocol design questions and answering protocol related questions from site investigators.
  • Work in close collaboration with the pharmacovigilance team to ensure adequate overview of the safety signals in the ongoing trials.
  • Interpretation of clinical trials results and contribute to clinical development strategy
  • Work in close collaboration with the data management and statistics team to ensure proper analysis of clinical trial results.
  • Writing of medical section in investigator brochure and other regulatory documents.
  • Contributing to writing clinical study report.
  • Contributing to publications, data presentation at scientific meetings, and manuscript writing.

Your profile:

Essential:

  • Graduate of a recognized school of medicine with an M.D. degree or equivalent with more than 5 years’ experience pharma experience (including in big pharma) this time spent should not include consulting or academia and consulting or academia should not be most recent job.
  • Board Certification, Eligibility, or fellowship training in Oncology is required.
  • Must have experience in clinical strategy in developing molecules from with experience in early phase clinical studies especially with monoclonal antibodies.
  • Demonstrated experience in clinical report writing and publishing.
  • Established understanding of pharmacokinetic and pharmacodynamic activities, including biomarkers and pre-clinical studies.
  • Should have a strong scientific understanding and the importance in clinical studies.

Desirable:

  • Specialty training in Immuno-Oncology, Tumor Immunology, or Immunotherapy.
Competencies, Skills and Behaviors

Technical Competencies

Essential:

  • Experience in medical monitoring of phase I/II clinical studies in industry, CRO or academic setting.
  • Experience in protocol writing and preparation of submission to regulatory authorities.
  • Experience in trial data analysis, interpretation, reporting and presentation (oral presentation, posters, publications).
  • The applicant must be able to read, write and speak English.

Desirable:

  • Experience in communication with FDA/EMA (e.g. cooperation on an industry sponsored phase 3 trial).
  • Previous participation or coordination of advisory boards.
  • Training in statistics or clinical trial methodology.

Additional Skills/ Behaviors

  • Highly motivated, dynamic physicians with aspiration to evolve and develop in the clinical development space.
  • Strong interpersonal, presentation, and excellent written and verbal communication skills.
  • Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
  • Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
  • Develops technical and/or business solutions to complex problems.
  • Demonstrated ability in decision-making, influencing, leadership, and affecting change by using a collaborative approach.
  • Results orientated work ethic and a positive, can-do attitude.
  • Strong organizational and time management skills.
  • Leads or manages the work of others by providing guidance to subordinates based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
  • Works on complex problems where analysis of situations or data requires an in[1]depth evaluation of various factors.
  • Works on abstract problems across functional areas of the business.
  • Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
  • Comfortable challenging the status quo and bringing forward innovative solutions.
  • Ability to build strong partnerships and drive role clarity across cross-functional teams as well as with external organizations.
  • Highly motivated, self-driven and dependable.
  • Willing and able to be “hands on” and willing to “roll-up sleeves” and delve into details as needed.
  • Ensures budgets and schedules meet corporate requirements.
  • Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major customers.

Job Features

Job CategoryCLINICAL DEVELOPMENT

Provides the strategic direction and clinical development plans (definition and updates). Is a permanent member of Core team, leader of the clinical sub-team and depending on the program, may also be ...

Key responsibilities:
  • Actively contributes to the development and implementation of company’s strategy for the area and the standardization of best practices
  • Supervise projects within the area, proving technical expertise and best practices to the area TMs and ensuring the right networks are developed, internally and externally
  • Assess potential future activities from a scientific perspective and estimate the resources required, including costs estimation
  • Review complex projects within the area to promote innovative approaches that can lead to the generation of IP (patents or trade secrets)
  • Liaise with key customers, supporting the Sales Team, to guarantee an informed discussion about company’s technical competencies and capabilities
  • Ensure there is a continuous improvement mindset in the project implementation to enhance productivity, decrease costs and deliver the best service to our customers
  • Speak at Scientific Events and represent the company in international scientific forums
  • Address gaps in technical competencies by coaching and developing team members with the area
  • Lead multiple work fronts and ensure the implementation of best practice improvements within the area
  • Show business acumen, see the big picture and understand the impact of decisions on the business
  • Is regarded as a Subject Matter Expert within the company
  • Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of company´s policies, systems and procedures (COPs, HBR, SOPs and others)
  • Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice
Your profile:
  • PhD in Chemistry, Chemical Engineering, Materials Sciences, Pharmaceutical Technology or similar scientific field
  • 12-18 years of relevant experience in Research & Development and/or Operations in the Pharmaceutical Industry. A Ph.D. degree in a relevant scientific field is typically considered equivalent to 4 years of relevant experience
  • Expert in Chemical Engineering, Chemistry, Organic Chemistry and Unit Operations, or of Reaction Engineering, Heat Transfer, Scale-up, Process Safety and Industrial Operations, or of drug product unit operations, solids flow phenomena and process equipment
  • Knowledge of mathematics, preferably data management, statistics and first principles modelling (preferred)
  • Fluency in English is a requirement
  • Computer literate with good working knowledge of the MS Office package
  • Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.

Job Features

Job CategoryTECHNICAL R&D

Actively contributes to the development and implementation of company’s strategy for the area and the standardization of best practices. Supervise projects within the area, proving technical exper...

Key responsibilities:

  • Act as a strategic driver to build and implement a sustainable transversal QMS Procedural Document (ProcDoc) / Training Framework driving the day-to-day GxP development activities
  • Evaluate operations from a strategic level to ensure that the QMS consistently meet quality and regulatory requirements from a Procedural Document and Training perspective
  • Take a lead role in the transversal QMS Procedural Document & Training Governance ensuring harmonization, efficiencies and simplification where appropriate
  • In collaboration with Business stakeholders (incl. senior leaders / process owners), develop and implement streamlined processes / procedural documents compliant with regulatory, industry, and internal quality standards
  • Drive and ensure continuous alignment with QMS ProcDoc / Training principles and ways of working across the different functional areas through engaging with key stakeholders, functional teams, and Process Owners
  • Provide oversight for the development and maintenance of the Quality Management System and related electronic systems, processes and procedures that ensure compliance with internal and external standards
  • Coach and lead Business stakeholders and Quality representatives by providing leadership, expert advice, support and management for translating QMS ProcDoc & Training strategy into operations
  • Foster a change management culture to facilitate adoption and usage of new ways of working.  Act as a “Change Agent” to drive the culture of process improvement throughout the organization
  • Management and reporting of quality key performance indicators related Procedural Document and Training Management

Your profile:

  • At least 15 years ‘experience in Pharma Industry, with at least 10 years in QA and/or QMS roles
  • Master’s degree in Science
  • Expertise in Quality Management Systems in a regulated, agile, mid-size biopharmaceutical company; in transversal GXP (preferably GCP) Quality Management System and related operations
  • Ability to be a strategical thinker and be a driver to bring efficiencies and simplifications in daily activities
  • Having demonstrated the ability to drive significant changes in a Quality Management organization
  • Experience in strategic partnering with senior leaders and quality representatives
  • A comprehensive working knowledge of data integrity and risk management (risk assessment and risk mitigation)
  • A good and thorough understanding of current regulatory requirements.
  • Ability to interpret current regulations and requirements is essential
  • Excellent verbal and written communication and interpersonal skills
  • Excellent presentation skills and ability to present content in front of senior management
  • Rigor, flexibility, adaptability, and organization
  • Pragmatism focused on efficiency and continuous improvement
  • Technical skills in view of system / application / software related activities

Job Features

Job CategoryQUALITY ASSURANCE/COMPLIANCE

Act as a strategic driver to build and implement a sustainable transversal QMS Procedural Document (ProcDoc) / Training Framework driving the day-to-day GxP development activities Evaluate operations...

Posted 11 months ago

Key responsibilities:

  • Act as a strategic driver to evaluate, optimize and implement the pro-active, fit-for-purpose and risk-based Clinical Quality Strategy ensuring compliance during the day-to-day clinical drug development activities
  • Drive the quality culture and create quality awareness throughout the clinical development organization
  • Drive effective planning/project management of Clinical Development Quality activities across DPI portfolio
  • Lead/manage a team of Clinical Development Quality Leads ensuring proper risk-based quality support at a project level
  • Allocate dedicated compliance resources to adequately support the respective Clinical Development activities
  • Establish & monitor operational quality objectives of Clinical Development Quality Leads (applying cascading mechanism supporting the departmental Quality and DLT Objectives) and ensure timely Quality Plan development and execution in line with business/project timelines
  • Coach and lead Quality representatives and Business stakeholders by providing leadership, expert advice, support and management for translating the Quality strategy into operations
  • Contribute to preferred CRO/Vendor selection and qualification process, assess relevant CROs procedures during selection process
  • Provide clinical development quality oversight and contribute / participate during CRO/Vendor Governance meetings
  • Build collaborative working relationships with business stakeholders (including senior leaders) and ensure adequate communication within the compound-specific teams and cross-functional Quality peers
  • Drive and ensure continuous alignment on the clinical development quality ways of working across the different projects/clinical trials through engaging with key stakeholders and functional teams
  • Oversee and/or contribute to compound-specific Regulatory Authority Inspections / Due Diligence Activities
  • Ensure adequate Audit / CAPA support of Clinical Development Quality Leads, by assisting the DPI business stakeholders to ensure proper CAPA formulation and follow-up
  • Might act as Clinical Development Quality Lead of a specific project or as back-up if required

Your profile:

  • At least 15 years’ experience in an agile, mid-size biopharmaceutical company, with at least 10 years in Clinical Quality
  • Master’s degree in Science
  • Ability to be a strategical thinker and be a driver to bring efficiencies and simplifications in daily activities
  • Having demonstrated the ability to drive significant changes in a Clinical Quality Management organization
  • Experience in strategic partnering with senior leaders and quality representatives
  • A comprehensive working knowledge of data integrity and risk management (risk assessment and risk mitigation)
  • Capacity to think strategically and to keep an overall view while bringing efficiency to daily detailed activities. Ability to make timely and appropriate decisions as related to the GCP expert and client area
  • Capability to quickly analyze problems, communication options and take appropriate action for resolution
  • Demonstrates consistent judgement under usual business conditions. Involves others in decision-making processes as appropriate
  • Effective cross-functional and cross-cultural skills
  • Global business thinking within GCP expert & client area
  • A good and thorough understanding of current regulatory requirements.
  • Ability to interpret current regulations and requirements is essential
  • Excellent verbal and written communication and interpersonal skills
  • Excellent presentation skills and ability to present content in front of senior management
  • Rigor, flexibility, adaptability, and organization
  • Pragmatism focused on efficiency and continuous improvement
  • Technical skills in view of system / application / software related activities

Job Features

Job CategoryQUALITY ASSURANCE/COMPLIANCE

Act as a strategic driver to evaluate, optimize and implement the pro-active, fit-for-purpose and risk-based Clinical Quality Strategy ensuring compliance during the day-to-day clinical drug developme...

Key responsibilities:

  • As Subject matter expert, you will be responsible for the technical strategic programme in the field of continuous tableting
  • Responsible for portfolio of projects within the programme, from ideation to launch including prioritisation, governance, resourcing and overall budget management
  • Promotes the scientific excellence and innovation in the field of continuous tableting and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
  • Lead the development and implementation of the R&D strategy for continuous tableting
  • Supervise projects within the field of continuous tableting, providing technical expertise and support to the project leads ensuring the right networks are developed internally and externally
  • Review complex projects within the area to promote innovative approaches leading to the generation of IP (patents or trade secrets)
  • Liaise with key customers, supporting the Sales Team, to guarantee an informed discussion about Hovione technical competencies and capabilities
  • Speak at Scientific Events and represent the company in international scientific forums
  • Ensure the strategic programme supports business strategy and meets market needs
  • Carry out tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice

Your profile:

  • PhD in Chemistry, Chemical Engineering, Materials Sciences, Pharmaceutical Technology or similar scientific field
  • Typically requires 12-18 years of relevant experience in Research & Development and/or Operations in the Pharmaceutical Industry. A Ph.D. degree in a relevant scientific field is typically considered equivalent to 4 years of relevant experience.
  • Demonstrated experience in the field of continuous tableting, developing novel formulations, establishing pipeline of new products
  • Previous experience in both internal and external stakeholder management
  • Experience in establishing external collaborations and licensing technologies
  • Fluency in English is a requirement
  • Computer literate with good working knowledge of the MS Office package
  • Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down

Job Features

Job CategoryPHARMACEUTICAL DEVELOPMENT

As Subject matter expert, you will be responsible for the technical strategic programme in the field of continuous tableting. Responsible for portfolio of projects within the programme, from ideation ...

Posted 11 months ago

Key responsibilities:

  • As Subject matter expert, you will be responsible for the technical strategic programme in the field of Inhalation
  • Responsible for portfolio of projects within the programme, from ideation to launch including prioritisation, governance, resourcing and overall budget management
  • Promotes the scientific excellence and innovation in the field of Inhalation and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
  • Lead the development and implementation of the R&D strategy for Inhalation
  • Supervise projects within the field of Inhalation, providing technical expertise and support to the project leads ensuring the right networks are developed internally and externally
  • Review complex projects within the area to promote innovative approaches leading to the generation of IP (patents or trade secrets)
  • Liaise with key customers, supporting the Sales Team, to guarantee an informed discussion about Hovione technical competencies and capabilities
  • Speak at Scientific Events and represent the company in international scientific forums
  • Ensure the strategic programme supports business strategy and meets market needs
  • Carry out tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice

Your profile:

  • PhD in Chemistry, Chemical Engineering, Materials Sciences, Pharmaceutical Technology or similar scientific field
  • Typically requires 12-18 years of relevant experience in Research & Development and/or Operations in the Pharmaceutical Industry. A Ph.D. degree in a relevant scientific field is typically considered equivalent to 4 years of relevant experience.
  • Demonstrated experience in the field of inhalation, developing novel formulations, establishing pipeline of new products
  • Previous experience in both internal and external stakeholder management
  • Experience in establishing external collaborations and licensing technologies
  • Fluency in English is a requirement
  • Computer literate with good working knowledge of the MS Office package
  • Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down

Job Features

Job CategoryPHARMACEUTICAL DEVELOPMENT

As Subject matter expert, you will be responsible for the technical strategic programme in the field of Inhalation. Responsible for portfolio of projects within the programme, from ideation to launch ...

Key responsibilities: 
  • Actively contributes to the development and implementation of compnay’s strategy for the area and the standardization of best practices
  • Supervise projects within the area, proving technical expertise and best practices to the area TMs and ensuring the right networks are developed, internally and externally
  • Assess potential future activities from a scientific perspective and estimate the resources required, including costs estimation
  • Review complex projects within the area to promote innovative approaches that can lead to the generation of IP (patents or trade secrets)
  • Liaise with key customers, supporting the Sales Team, to guarantee an informed discussion about company technical competencies and capabilities
  • Ensure there is a continuous improvement mindset in the project implementation to enhance productivity, decrease costs and deliver the best service to our customers
  • Speak at Scientific Events and represent the company in international scientific forums
  • Address gaps in technical competencies by coaching and developing team members with the area
  • Lead multiple work fronts and ensure the implementation of best practice improvements within the area
  • Show business acumen, see the big picture and understand the impact of decisions on the business
  • Is regarded as a Subject Matter Expert within the company
  • Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of company´s policies, systems and procedures (COPs, HBR, SOPs and others)
  • Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice
  Your profile:
  • PhD in Chemistry, Chemical Engineering, Materials Sciences, Pharmaceutical Technology or similar scientific field
  • Typically requires 12-18 years of relevant experience in Research & Development and/or Operations in the Pharmaceutical Industry. A Ph.D. degree in a relevant scientific field is typically considered equivalent to 4 years of relevant experience.
  • Expert in Chemical Engineering, Chemistry, Organic Chemistry and Unit Operations, or of Reaction Engineering, Heat Transfer, Scale-up, Process Safety and Industrial Operations, or of drug product unit operations, solids flow phenomena and process equipment
  • Knowledge of mathematics, preferably data management, statistics and first principles modeling (preferred)
  • Fluency in English is a requirement
  • Computer literate with good working knowledge of the MS Office package
  • Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down

Job Features

Job CategoryPHARMACEUTICAL DEVELOPMENT

- Actively contributes to the development and implementation of compnay’s strategy for the area and the standardization of best practices. Supervise projects within the area, proving technical expe...

Key responsibilities:

  • Actively contributes to the development and implementation of company’s strategy for the area and the standardization of best practices
  • Supervise projects within the area, proving technical expertise and best practices to the area TMs and ensuring the right networks are developed, internally and externally
  • Assess potential future activities from a scientific perspective and estimate the resources required, including costs estimation
  • Review complex projects within the area to promote innovative approaches that can lead to the generation of IP (patents or trade secrets)
  • Liaise with key customers, supporting the Sales Team, to guarantee an informed discussion about company technical competencies and capabilities
  • Ensure there is a continuous improvement mindset in the project implementation to enhance productivity, decrease costs and deliver the best service to our customers
  • Speak at Scientific Events and represent the company in international scientific forums
  • Address gaps in technical competencies by coaching and developing team members with the area
  • Lead multiple work fronts and ensure the implementation of best practice improvements within the area
  • Show business acumen, see the big picture and understand the impact of decisions on the business
  • Is regarded as a Subject Matter Expert within the company
  • Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of company’s policies, systems and procedures (COPs, HBR, SOPs and others)
  • Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice
 

Your profile:

  • PhD in Chemistry, Chemical Engineering, Materials Sciences, Pharmaceutical Technology or similar scientific field
  • Typically requires 12-18 years of relevant experience in Research & Development and/or Operations in the Pharmaceutical Industry. A Ph.D. degree in a relevant scientific field is typically considered equivalent to 4 years of relevant experience.
  • Expert in Chemical Engineering, Chemistry, Organic Chemistry and Unit Operations, or of Reaction Engineering, Heat Transfer, Scale-up, Process Safety and Industrial Operations, or of drug product unit operations, solids flow phenomena and process equipment
  • Knowledge of mathematics, preferably data management, statistics and first principles modelling (preferred)
  • Fluency in English is a requirement
  • Computer literate with good working knowledge of the MS Office package
  • Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down

Job Features

Job CategoryPHARMACEUTICAL DEVELOPMENT

- Actively contributes to the development and implementation of company’s strategy for the area and the standardization of best practices. Supervise projects within the area, proving technical exp...

Posted 12 months ago

Key responsibilities:

  • Apply strategic-thinking and forward planning to the area projects and implement the necessary actions to promote faultless execution
  • Assure the adequate planning of area activities in line with clients and internal requirements and ensuring the liaison with relevant third parties
  • Ensure that all projects are staffed appropriately and that the materials requirements of the area are met to guarantee all area’s responsibilities are met and the group is able to exceed customers’ expectations
  • Ensure the information flow between all R&D areas and other relevant stakeholders
  • Ensure scientific development activities occur with the right level of guidance and technical know-how
  • Propose new technologies and methodologies and the necessary investments and resources taking in account both specific driven project objectives and the group scientific and technical objectives and support in their implementation
  • Review and approve the protocols, reports and documentation prepared in the Area
  • Ensure the continuous improvement and subsequent implementation of new methodologies that can efficiently support process development
  • Promote scientific activities (e. seminars, congress participations, innovation ideas, papers and publications) and innovation within the team and encourage the sharing of knowledge with other teams
  • Be part of problem-solving processes as required by the team
  • Coordinate the TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all TMs are aligned and motivated towards achieving goals, values and culture by promoting their personal and professional development whilst maximizing productivity.
  • Develop and propose for superior approval the activity plan and related budget for the Area under responsibility in line with the unit's strategy, in order to align activities with area strategic objectives
  • Monitor area´s budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures
  • Ensure compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of policies, systems and procedures (COPs, HBR, SOPs and others) within his/ her TMs
  • Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice

Your profile:

  • Masters’ degree in Chemistry, Engineering (e.g. Chemical, Mechanical, Biological), Materials Sciences, Pharmaceutical Technology, or related field
  • Typically requires 10 years of relevant experience in Research & Development and/or Operations in the Pharmaceutical Industry and coordinating a team
  • Proven leadership experience
  • Effective time management skills and the ability to multitask
  • Track record of overachieving targets
  • Possess extensive knowledge of oral drug product formulation, spray drying and amorphous solid dispersions or pharmaceutical unit Operations,  scale-up, solids flow phenomena and process equipment principles and practices and is able to effectively share them with others
  • Good communication skills (verbal and written)
  • Skilled at managing complex processes and tools
  • Fluency in English is a requirement
  • Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down

Job Features

Job CategoryPHARMACEUTICAL DEVELOPMENT

Apply strategic-thinking and forward planning to the area projects and implement the necessary actions to promote faultless execution. Assure the adequate planning of area activities in line with clie...

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