JETZT BEWERBEN
von: Viatris Pharma GmbH | Ort: Steinhausen
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:
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Acting as Deputy QP (FvP), including batch disposition, recalls, and ensuring GDP-compliant distribution
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Leading and maintaining the local Quality Management System (QMS) in line with GMP/GDP standards
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Serving as primary quality contact for Swissmedic, cantonal authorities, and external partners
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Conducting management reviews, self-inspections, and release of reworked batches/products
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Acting as Person Responsible for Regulatory Compliance (PRRC) under the Swiss Medical Devices Ordinance
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Managing responsibilities related to narcotics and controlled substances according to Swiss regulations
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Handling deviations, complaints, CAPA activities, and product recalls
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Approving and maintaining quality-relevant documentation (SOPs, PQRs, Technical Quality Agreements)
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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:
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University degree in pharmacy or a scientific discipline (e.g., chemistry, biology)
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8+ years of experience in the pharmaceutical industry, including minimum 5 years in Quality Assurance
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Proven experience as Swiss QP (FvP) or Deputy QP (minimum 3 years)
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In-depth knowledge of regulatory requirements (TPA, MPLO, GDP, GMP, BetmG)
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Strong decision-making and communication skills, able to act independently and responsibly
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Fluency in English and German (spoken and written); French is a plus
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Experience in liaising with Swissmedic and international regulatory authorities is an advantage
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JETZT BEWERBEN