Product Quality Lead

vor 4 Wochen


Basel, Schweiz Coopers Group AG Vollzeit

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.

Schedule:

- 8 Hour Shift

Ability to commute/relocate:

- Basel, BS: Reliably commute or planning to relocate before starting work (required)


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