Senior Quality Assurance Manager

CK QLS

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Senior Quality Assurance Manager (m/f/d) Location: Zug SwitzerlandSchedule: Full-time (100%)Start Date: As soon as possibleAbout the Company Our client is a global healthcare organization dedicated to empowering people to live healthier lives at every stage. With a diverse portfolio that includes brand-name medicines, generics, complex generics, and innovative therapeutic solutions, the company is committed to advancing patient health, improving access, and building healthier communities worldwide.The Role We are seeking a Senior Manager Quality Assurance and Deputy QP (FvP) to ensure regulatory compliance and product quality across several Swiss legal entities. This is a key leadership role within Quality Management, working closely with regulators, external partners, and internal stakeholders.Key Responsibilities:
  • Act as Deputy QP (FvP), including batch disposition, recalls, and ensuring GDP-compliant distribution
  • Lead and maintain the local Quality Management System (QMS) in line with GMP/GDP standards
  • Serve as primary quality contact for Swissmedic, cantonal authorities, and external stakeholders
  • Conduct management reviews, self-inspections, and release of reworked batches/products
  • Act as Person Responsible for Regulatory Compliance (PRRC) under Swiss Medical Devices Ordinance
  • Manage compliance related to narcotics and controlled substances in Switzerland
  • Handle deviations, complaints, CAPA activities, and product recalls
  • Approve and maintain SOPs, PQRs, and Technical Quality Agreements
  • Support supplier qualification and oversee training activities
Your Profile
  • University degree in pharmacy or related scientific discipline (e.g., chemistry, biology)
  • At least 8 years of pharmaceutical industry experience, including 5+ years in Quality Assurance
  • Proven track record as Swiss QP (FvP) or Deputy QP (minimum 3 years)
  • Strong knowledge of TPA, MPLO, GDP, GMP, BetmG regulations
  • Independent decision-maker with excellent communication skills
  • Fluent in English and German; French is an asset
  • Experience liaising with Swissmedic and international regulatory bodies is a plus
What's on Offer
  • Competitive compensation and benefits
  • Inclusive and diverse work environment
  • Excellent opportunities for career development and progression
  • Work-life balance initiatives
  • A collaborative culture with the opportunity to make a real impact
To apply, please reach out directly to CK QLS to discuss your application and learn more about the client.

CK QLS