Senior Quality Assurance Manager With German Language Skills
Viatris Pharma GmbH
Steinhausen, Zoug
CDI
Temps-plein
Il y a 29 jours
The Role & What You Will Be DoingAs 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 distributionLeading and maintaining the local Quality Management System (QMS) in line with GMP/GDP standardsServing as primary quality contact for Swissmedic, cantonal authorities, and external partnersConducting management reviews, self-inspections, and release of reworked batches/productsActing as Person Responsible for Regulatory Compliance (PRRC) under the Swiss Medical Devices OrdinanceManaging responsibilities related to narcotics and controlled substances according to Swiss regulationsHandling deviations, complaints, CAPA activities, and product recallsApproving and maintaining quality-relevant documentation (SOPs, PQRs, Technical Quality Agreements)Supporting supplier qualification and overseeing training activitiesAbout Your Skills & ExperienceFor 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 AssuranceProven 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 responsiblyFluency in English and German (spoken and written); French is a plusExperience in liaising with Swissmedic and international regulatory authorities is an advantage jidf767b47a jit0832a jiy25a