Clinical Development Quality Lead
vor 2 Wochen
About Debiopharm
Debiopharm is a biopharmaceutical company based in Switzerland that focuses on developing innovative therapies for oncology and infectious diseases. Our mission is to improve patient outcomes and quality of life through our research and development efforts.
Your Role
We are seeking a Clinical Development Quality Lead to join our team. As a key member of our Quality Management team, you will be responsible for implementing our quality strategy and ensuring compliance with regulatory requirements.
Key Responsibilities
- Develop a risk-based compliance program to ensure document and data accuracy
- Contribute to the selection and qualification of CROs and vendors
- Collaborate with the Clinical Trial Manager to ensure proper setup and oversight of outsourced CRO activities
- Provide compliance support and oversight of quality events that may impact the validity of clinical studies
- Collaborate cross-functionally to develop and review critical clinical study documents
- Identify areas for improvement based on risk-based compliance activities and audit observations
- Lead regulatory authority inspections and due diligence activities
Requirements
- University degree in sciences or relevant academic background
- 6-8 years' experience in clinical quality management and compliance
- Experience in managing and conducting GCP audits
- Strong knowledge of GCP, CFR Title 21, and regulatory guidelines
About the Company
Debiopharm offers a dynamic and international work environment with a long-term vision. We value collaboration, innovation, and entrepreneurship, and we are committed to improving patient outcomes and quality of life through our research and development efforts.
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