
Senior QA Manager
- Zug
- Unbefristet
- Vollzeit
Employment Type: Full-time (100%)
Start Date: ASAPAre you a seasoned Quality Assurance professional with a strong background in pharmaceutical compliance and regulatory affairs? We are currently recruiting for an exciting opportunity with a leading global healthcare organization based in Zug. This is a strategic role offering the chance to make a real impact in a dynamic and fast-paced environment.Your Responsibilities:As Senior Quality Assurance Manager, you will be responsible for:
- Acting as Deputy QP (FvP), including batch disposition, product recalls, and ensuring GDP-compliant distribution.
- Leading and maintaining the local Quality Management System (QMS) in accordance with GMP/GDP standards.
- Conducting management reviews, self-inspections, and releasing reworked batches/products.
- Acting as Person Responsible for Regulatory Compliance (PRRC) under Swiss Medical Devices Ordinance.
- Managing responsibilities related to narcotics and controlled substances under Swiss law.
- Handling deviations, complaints, CAPA activities, and product recalls.
- Approving and maintaining quality documentation (SOPs, PQRs, Technical Quality Agreements).
- Supporting supplier qualification and overseeing training activities.
- A university degree in pharmacy or scientific discipline (e.g., chemistry, biology).
- At least 8 years of experience in the pharmaceutical industry, including 5+ years in Quality Assurance.
- Proven experience as a Swiss QP (FvP) or Deputy QP (minimum 3 years).
- Strong knowledge of Swiss regulatory requirements (TPA, MPLO, GDP, GMP, BetmG).
- Excellent decision-making and communication skills, with the ability to act independently.
- Fluency in English and German (spoken and written); French is a plus.
- Experience liaising with Swissmedic and international regulatory authorities is an advantage.
- Work in a collaborative and purpose-driven environment.
- Be part of a global organization committed to improving healthcare access and quality.
- Enjoy a competitive compensation package and career development opportunities.
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