Senior Manager QA-GCP (m/w/d)
We are currently looking for a highly qualified Senior Manager QA-GCP (m / f / d) for an aspiring biotech start-up. In this key position, you will make a significant contribution to the realization of the company's goals by managing and executing QA oversight, performing audits and implementing a GCP-related QMS.
Key Responsibilities :
- Lead and enhance the Clinical Quality Assurance program to ensure the quality and compliance of clinical trials
- Conduct audits and inspections (CROs, sites, documentation) to ensure compliance with applicable GxP guidelines (GCP, GLP)
- Collaborate with clinical teams to ensure regulatory requirements and internal standards are met throughout the development process
- Support the development and implementation of QA policies, processes, and SOPs for clinical studies
- Manage and track deviations, CAPAs (Corrective and Preventive Actions), and risk management processes
- Prepare for and support regulatory inspections (FDA, EMA, etc.), including addressing queries from health authorities
- Provide leadership, mentoring, and development of a team of QA professionals
- Ensure continuous improvement of the quality system and adherence to best practices in clinical research
Your Profile :
- Degree in Life Sciences, Pharmacy, Medicine, or a related field
- Professional experience in clinical quality assurance within the pharmaceutical / biotech industry or at CROs
- Strong knowledge of GCP and other relevant regulatory requirements (FDA, EMA, ICH)
- Experience in conducting GCP audits and supporting regulatory inspections
- Excellent communication and organizational skills, along with strong analytical and problem-solving abilities
- Leadership experience with the ability to work in a dynamic and fast-paced environment
- Proficiency in English is a must
- Experience in QA-GLP is a plus
I look forward to receiving your CV, your desired salary and your earliest possible start date. A covering letter is not necessary.
Senior Manager QA-GCP (m/w/d)
In this key position, you will make a significant contribution to the realization of the company's goals by managing and executing QA oversight, performing audits and implementing a GCP-related QMS. Conduct audits and inspections (CROs, sites, documentation) to ensure compliance with applicable GxP ...
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