Product Quality Lead

vor 2 Wochen

Basel, Schweiz Coopers Group AG Vollzeit

Product Quality Lead

For a fast-growing biotechnology firm that is focused on the development and production of innovative and life-changing products, we are seeking a highly skilled and motivated Product Quality Lead to join the team

As the Product Quality Lead, you will play a key role in ensuring the quality of our products from development to commercialization. You will work closely with cross-functional teams to establish and maintain quality systems, ensure compliance with regulatory requirements, and drive continuous improvement in product quality.

**The role**:
Develop and implement quality systems and processes to ensure compliance with regulatory requirements, industry standards, and customer expectations.
- Establish and maintain product quality metrics and performance indicators, and drive continuous improvement initiatives to achieve and exceed targets.
- Work closely with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure that products meet quality and performance specifications.
- Conduct risk assessments, root cause analyses, and investigations to identify and resolve quality issues and implement corrective and preventive actions.
- Advice / leads Complex quality issues and influence global solutions to ensure continuous drug supply to patients

**Your profile**:

- High level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science
- At least 10 years of experience within pharmaceutical and biotech products. Experience within QA operation, production, development and commercial environment
- Proven track record with FDA, EMEA and/or other Health Authorities
- Deep understanding of the GMP & GDP requirements

Sounds like a great job?

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