Senior QA Manager GMP/GDP

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.