Overview
As Senior Manager Quality Assurance and Deputy QP (FvP), you will be instrumental in ensuring regulatory compliance and maintaining high standards of product quality across multiple Swiss legal entities. This role combines strategic leadership with hands-on operational oversight, supporting both pharmaceutical and medical device activities under Swiss regulations.
* Serve as Deputy QP (FvP), including batch disposition, product recalls, and GDP-compliant distribution
* Lead and maintain the local Quality Management System (QMS) in alignment with GMP/GDP standards
* Act as primary quality contact for Swissmedic, cantonal authorities, and external partners
* Conduct management reviews, self-inspections, and release of reworked batches/products
* Fulfill duties as Person Responsible for Regulatory Compliance (PRRC) under the Swiss Medical Devices Ordinance
* Manage compliance related to narcotics and controlled substances per Swiss law
* Oversee deviation handling, complaints, CAPA activities, and product recalls
* Approve and maintain quality documentation including SOPs, PQRs, and Technical Quality Agreements
* Support supplier qualification and coordinate internal training programs
* University degree in pharmacy or a scientific discipline (e.g., chemistry, biology)
* Minimum 8 years of experience in the pharmaceutical industry, with at least 5 years in Quality Assurance
* Proven track record as Swiss QP (FvP) or Deputy QP (minimum 3 years)
* Deep understanding of Swiss regulatory frameworks: TPA, MPLO, GDP, GMP, BetmG
* Strong decision-making and communication skills, with the ability to act independently and responsibly
* Fluency in English and German (spoken and written); French is a plus
* Experience liaising with Swissmedic and international regulatory authorities is highly desirable
* Open to relocation within Switzerland or internationally as required
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Quality Assurance and Management
Industries
* Pharmaceutical Manufacturing and Biotechnology Research
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