Regulatory Compliance Manager
vor 2 Monaten
Debiopharm International SA is a biopharmaceutical company dedicated to developing innovative therapies that address high unmet medical needs. Our company is committed to improving patient outcomes and quality of life through our research in oncology and infectious diseases.
Job SummaryWe are seeking a highly skilled Clinical Development Quality Lead to join our Quality Management – R&D organization based at our Headquarters in Lausanne. The successful candidate will contribute to the implementation of our Quality Strategy, supporting our day-to-day clinical trial activities from a cross-functional end-to-end perspective.
Key Responsibilities- Develop a risk-based compliance program to ensure document and data accuracy, resulting in dossier acceptability by out-licensing partners.
- Contribute to the selection and qualification of CROs and vendors, ensuring compliance with regulatory requirements.
- Collaborate with the Clinical Trial Manager and other Functional Area Representatives to ensure proper setup and oversight of outsourced CRO activities.
- Provide compliance support and contribute to the oversight of quality events that may jeopardize the validity of clinical studies.
- Collaborate cross-functionally to develop and review critical clinical study documents, ensuring cross-document consistency.
- Apply a risk-based approach to identify the need for and conduct co-auditing activities and quality visits with DPI and/or CRO representatives.
- Provide continuous compliance support by acting as an internal advisor on relevant procedures and regulations.
- Create Key Quality Indicators (KQIs) 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.
- Provide Audit/CAPA support to the execution of the Master Audit Plan and assist in the formulation and follow-up of CAPAs.
- Support the development/maintenance of QM and ClinDev-related Procedural Documents.
- 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).
- Excellent knowledge of GCP, current and strong working knowledge of GCP, CFR Title 21, and regulatory guidance documents, including ICH quality, clinical, multidisciplinary guidance documents, and 21 CFR Part 11 compliance.
- Strong experience in the mechanism of multiple QA vendor 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.
Debiopharm offers employees:
- An international, highly dynamic environment with a long-term vision.
- Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry.
- Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry.
- Participation in a company where innovation, people, and entrepreneurship are the fundamental keys to success.
- Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities.
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