CK QLS

Senior Quality Assurance Manager

Senior Quality Assurance Manager (m/f/d) Location: Zug Switzerland

Schedule: Full-time (100%)

Start Date: As soon as possible

About 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.