Senior Quality Assurance Manager (m/f/d) with German language skills

The Role & What You Will Be Doing

As Senior Manager Quality Assurance and Deputy QP (FvP), you will play a key role in ensuring regulatory compliance and product quality across several Swiss legal entities. Your main responsibilities include:

• Acting as Deputy QP (FvP), including batch disposition, recalls, and ensuring GDP-compliant distribution
• Leading and maintaining the local Quality Management System (QMS) in line with GMP/GDP standards
• Serving as primary quality contact for Swissmedic, cantonal authorities, and external partners
• Conducting management reviews, self-inspections, and release of reworked batches/products
• Acting as Person Responsible for Regulatory Compliance (PRRC) under the Swiss Medical Devices Ordinance
• Managing responsibilities related to narcotics and controlled substances according to Swiss regulations
• Handling deviations, complaints, CAPA activities, and product recalls
• Approving and maintaining quality-relevant documentation (SOPs, PQRs, Technical Quality Agreements)
• Supporting supplier qualification and overseeing training activities

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• University degree in pharmacy or a scientific discipline (e.g., chemistry, biology)
• 8+ years of experience in the pharmaceutical industry, including minimum 5 years in Quality Assurance
• Proven experience as Swiss QP (FvP) or Deputy QP (minimum 3 years)
• In-depth knowledge of regulatory requirements (TPA, MPLO, GDP, GMP, BetmG)
• Strong decision-making and communication skills, able to act independently and responsibly
• Fluency in English and German (spoken and written); French is a plus
• Experience in liaising with Swissmedic and international regulatory authorities is an advantage

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