Senior Clinical Quality Assurance Manager

Title:

Senior Clinical Quality Assurance Manager

Company:

Ipsen Biopharm Ltd

Job Description:

Ipsen is a growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’ health and quality of life, providing effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases.

Why Ipsen?

• Patient-Focused: The patient is at the heart of everything we do, and improving their outcomes is the deliverable of every strategy.
• Employee Care: We care for our employees, who are the ambassadors making a real difference.
• Bold Leadership: We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions.
• Growth Opportunities: We offer a wealth of fulfilling challenges and growth opportunities in a fast-moving, game-changing organization.

About the Role

The Senior Manager Clinical Quality Assurance 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. In this role you will support the conduct of clinical studies and programs within the therapeutic area (TA) and ensure consistency and standardization in operational methodology and processes in their management.

Key Responsibilities

• Clinical Study QA Representative: For the clinical studies and programs assigned, work with the Clinical Research project manager to ensure good clinical practices and relevant regulatory requirements are met.
• Maintain a robust Clinical QMS: Support and facilitate the implementation and continuous improvement of clinical quality and operational processes.
• Quality 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.

Qualifications

• 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.

Ipsen is committed to fostering a diverse and inclusive workplace where all employees feel valued and empowered. If you feel that this could be the right next step for you, we would be delighted to engage with your application.

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IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.