Senior QA Manager GMP/GDP

Allschwil
9 months ago
Applications closed

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Senior QA Manager GMP/GDP

📍 Allschwil, Switzerland | 🕒 100% Full-time

📅 Contract Duration: 04.08.2025 – 31.07.2026 (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 (Apply online only) in all correspondence

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