Germany, Switzerland
Posted 3 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 and clinical development related 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 Category | LIFE SCIENCES, QUALITY ASSURANCE/COMPLIANCE |