Clinical Quality Assurance Manager
1 month ago
Ipsen is a global specialty-driven biopharmaceutical company focused on innovation and specialty care. Our mission is to make a sustainable difference by improving patients' health and quality of life through effective therapeutic solutions for unmet medical needs.
Why Ipsen?
- Patient-Centric: We put patients at the heart of everything we do, striving to improve their outcomes.
- Employee Empowerment: We care for our employees, who are the ambassadors making a real difference.
- Leadership: We attract and develop bold, agile, entrepreneurial individuals who take ownership of their decisions.
- Growth Opportunities: We offer a wealth of fulfilling challenges and growth opportunities in a fast-moving, game-changing organization.
The Senior Clinical Quality Assurance Manager contributes to a global team, ensuring the implementation of Ipsen quality policy and compliance with applicable regulations/directives for all activities within Research and Development (R&D) and Medical Affairs. This role supports the conduct of clinical studies and programs within the therapeutic area, ensuring consistency and standardization in operational methodology and processes.
Key Responsibilities
- Clinical Study QA Representative: Collaborate with the Clinical Research project manager to ensure good clinical practices and relevant regulatory requirements are met.
- Clinical Quality Management: Support and facilitate the implementation and continuous improvement of clinical quality and operational processes.
- Quality Event Management: Ensure proper management of all stages, including documentation, investigation, and CAPA definition of major/critical Quality Events and potential Serious Breaches.
- Assessment, Audit & Inspection: Prepare agenda, interviews, opening, closing, QA report, and recording into eQMS for assessments, conduct inspections, as well as supporting audit activities.
- Relevant qualification and proven experience in a similar environment.
- Knowledge of FDA/EMA global regulations and ICH GCP.
- Experience with GCP, GVP, GPEP, Quality System development, support, and maintenance.
- Commitment to making a real impact through your work.
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