Responsible Person (FvP) Quality - Swiss Pharma Supply Chain

About the role

A Swiss pharmaceutical supply chain company is looking for an experienced quality professional to act as the independent quality authority for technical release, manufacturing orders as contract giver and trade abroad of drug substances, drug products and finished products, in line with the Swiss Medicinal Products Licensing Ordinance (812.212.1).

Key responsibilities

• Ensure compliance with Swiss medicinal products legislation, Swissmedic requirements and GMP/GDP standards, and keep authorized activities within the approved Swissmedic licence scope.
• Act as the primary quality contact for Swissmedic and oversee technical release, including batch certificates, deviations, investigations and change controls.
• Make batch disposition decisions independently, without prior approval or override by management.
• Oversee trade abroad, including supply chain traceability and due diligence, and ensure suppliers, service providers and customers are qualified.
• Approve quality arrangements with CDMOs, external laboratories, service providers and, where applicable, MAHs, and ensure audits and quality risk management are applied across outsourced activities.
• Review and approve SOPs and quality documents, and oversee deviations, CAPAs, change controls, complaints, recalls and quality defect notifications.
• Participate in management reviews on quality and compliance and delegate operational quality activities to qualified personnel.

Required profile

• Degree in Pharmacy, Chemistry, Biology, Biotechnology, Pharmaceutical Sciences or an equivalent scientific discipline.
• Significant experience in GMP quality assurance, pharmaceutical manufacturing or its oversight, and technical release and/or batch disposition.
• Experience in GDP oversight, supplier qualification, outsourced manufacturing management and international pharmaceutical supply chains.
• Experience with biological and/or sterile products.
• Experience interacting with Swissmedic and/or other health authorities (EMA, FDA); being a registered EU or Swiss Responsible Person or Qualified Person is a plus.
• English and German (written and spoken) are required.

Required skills

• Strong understanding of Swiss GMP/GDP requirements, outsourced manufacturing models and risk-based quality oversight.
• Knowledge of international GxP regulations and the ability to apply them practically.
• Ability to assess complex multi-site manufacturing and testing documentation.
• Strong communication, stakeholder management, organizational and documentation skills.