Clinical Development Quality Lead

Switzerland
Posted 2 months ago

Key responsibilities:

  • Develop a “risk-based” compound-specific compliance program contributing to document / data accuracy, ultimately resulting in “dossier acceptability” by respective out-licensing partners (emphasis on eCTD Module 5)
  • Contribute to CRO/Vendor selection and qualification process, assess relevant CROs procedures during selection process to establish a pro-active quality approach, guaranteeing compliance with regulatory requirements
  • Collaborate with the Clinical Trial Manager and other Functional Area Representatives in the Study Team to ensure proper DPI set-up & oversight of outsourced CRO activities, with primary focus on critical data points (primary endpoints) and critical processes
  • Provide compliance support and contribute to “in process / ongoing” oversight through evaluation & follow-up on reported quality events potentially jeopardizing the validity of the clinical study
  • Collaborate cross-functionally to the development and review of critical clinical study documents to ensure cross-document consistency e.g. IB versus Clinical Trial Protocol versus Master Informed Consent Form, …
  • Applying the risk-based approach, identify the need to & conduct co-auditing activities / quality visits with DPI and / or CRO representatives
  • Provide continuous compliance support by acting as an internal advisor on relevant procedures and regulations to ensure correct interpretation and proper implementation
  • Create KQI to identify areas for improvement based on risk-based compliance activities and audit observations
  • Lead / contribute to compound-specific Regulatory Authority Inspections / Due Diligence Activities
  • Build collaborative working relationships and ensure adequate communication within the compound-specific study team and cross-functional Quality peers, assist in driving change to build a culture of compliance throughout the Clinical Development organization
  • Provide Audit / CAPA support to the execution of Master Audit Plan executed, assist the DPI business stakeholders to ensure proper CAPA formulation and follow-up
  • Provide support to the development / maintenance of QM andclinical developmentrelated procedural documents

Your profile:

  • University Degree in Sciences or relevant academic background
  • 6-8 years’ experience in the clinical setting of the pharmaceutical/biotech industry, including at least 3 years within Clinical Quality Management System & Compliance
  • Experience in managing and conducting GCP audits (CROs, TMF, Investigational Sites and CSR)
  • Excellence knowledge of GCP. Current and strong working knowledge of GCP, CFR Title 21 and regulatory guidance’s including, ICH quality, clinical, multidisciplinary guidance documents, and 21 CFR Part 11 compliance
  • Strong experience in the mechanism of multiple QA vendor’s oversight
  • Experience in setting and updating SOPs
  • 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
  • Fluent in English, French an asset

Job Features

Job CategoryLIFE SCIENCES, QUALITY ASSURANCE/COMPLIANCE

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