Requirements: English
Company: CK Group
Senior QA Manager GMP/GDP
Allschwil, Switzerland 100% Full-time
Contract Duration: 04.08 07.2026 (12 months)
Contractor Rate: CHF 77.96/hour
About the Opportunity: Join a dynamic, innovation-driven pharmaceutical environment and play a key role in ensuring the quality, safety, and compliance of investigational and commercial products. As a Senior QA Manager, you will provide GMP/GDP expertise across the product lifecycle, from development through to distribution. This position offers the opportunity to work cross-functionally with internal teams and external partners, contributing to quality excellence on a global scale.
Key Responsibilities:- Act as the quality assurance lead for assigned projects throughout the development and commercialization phases.
- Ensure all quality-related activities are initiated and completed in accordance with development milestones.
- Oversee compliance of product development, manufacturing, and control activities with applicable GMP/GDP standards.
- Provide expert guidance in managing deviations, complaints, OOS investigations, discrepancies, and CAPAs.
- Apply a risk-based quality management approach using Six Sigma concepts.
- Support the release process for drug substances (DS), drug products (DP), and investigational medicinal products.
- Approve master batch documentation, review batch records, and assess change controls.
- Collaborate with CMC and management teams to identify and address quality, regulatory, or lead time risks.
- Represent QA in CMC team meetings and audits.
- Draft and review GMP/GDP agreements with Contract Manufacturing Organizations (CMOs).
- Write, review, and approve internal SOPs and QA documentation.
- Monitor and review CMOs'' KPIs to support continuous quality system improvement.
- Perform DS and DP bulk release in line with internal SOPs.
Candidate Profile Education & Experience:- Advanced degree (MSc or equivalent) in Pharmacy, Chemistry, or a related scientific discipline.
- Minimum 5 years experience in QA within the pharmaceutical industry, with direct exposure to drug substance and/or drug product.
- Additional experience in pharmaceutical development, QC, analytical development, or production is highly desirable.
Technical Skills:- Solid understanding of pharmaceutical development, GMP manufacturing, quality control, packaging, and global distribution.
- In-depth knowledge of GMP/GDP regulations and their practical implementation.
- Proficiency in managing quality investigations and regulatory documentation.
Soft Skills:- Strong project management and prioritization abilities.
- Excellent interpersonal and communication skills; adept at managing stakeholders across functions.
- Proactive, autonomous, and assertive approach to problem solving and decision-making.
- Fluent in English (written and spoken); German is a plus.
Why Join Us? This is an exciting opportunity to contribute your quality expertise to impactful projects in a global pharmaceutical environment. You will collaborate with experienced professionals and help shape product integrity across a dynamic development portfolio.
Apply: It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference in all correspondence.