Product Quality Lead

Vor 5 Tagen

Basel, Schweiz Coopers Group AG Vollzeit

Are you currently looking to grow professionally and want to join an innovative and future-thinking organization based in Switzerland? If so, no need to look further.

**Product Quality Lead**

As Product Quality Lead you are the quality representative of the development strategy of the product, ensuring global supply of IMPs and commercial products.

**As PQL you will**:

- Be responsible for the E2E Compliance of one or several products, across the different manufacturing steps and the life cycle of the products
- Responsible for the implementation and Maintenance of Quality Risk Assessment and KPIs for products
- Ensures alignment of product changes and collaborates with key colleagues to develop strategies that maintain global supply while improving product robustness as in Tech Transfer, NPI
- Provides guidance and Quality input to the CQAs, specifications, comparability, and stability programs, Supports site and method transfers
- Coordinate product QA activities across (e.g. launch preparation within different hubs)
- Responsible for coordination and approval of the APQR
- Lead & coordinate Quality aspect for Due Diligences processes and integration of new acquisitions.
- Advice/lead Complex quality issues and influence global solutions to ensure continuous drug supply to patients.
- Collaborates closely with the rest of the Quality functions to ensure product quality requirements, issues, or solutions are promptly communicated at all appropriate levels
- Lead / QA representative of Product Governance boards

**Requirements**:

- A high-level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science.
- You have at least 10 years of experience from the pharmaceutical industry, preferably with experience within QA operation, production, development, and commercial environment.
- You have a strong GMP and GDP competence and understanding and are experience in manufacturing of biological drugs.
- Proven leadership ability to manage challenging decisions in a logical and compliance manner is a merit. Furthermore, you have good experience of working in projects.
- Excellent knowledge of English in both speech and writing.

Sounds like a great job?

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