Quality Assurance Lead - FvP

Position Summary 

We are seeking an experienced and Swissmedic-recognized Fachtechnisch verantwortliche Person (FvP) to support the establishment of a local pharmaceutical quality system in Switzerland and lead the company’s efforts to obtain and maintain a Pharmaceutical Establishment License (PEL). This role is critical in ensuring compliance with Swiss and EU GMP/GDP requirements and in enabling local operations such as importation, release, distribution, and oversight of pharmaceutical products.  

Key Responsibilities 

Quality System Establishment:  

• Design, implement, and maintain a fit-for-purpose Quality Management System (QMS) aligned with Swissmedic, EU GDP/GMP, and company global Quality and Compliance processes and standards  

• Draft, review, and approve SOPs, policies, and related quality documentation  

• Define quality metrics and processes for internal audits, deviations, CAPA, change control, and management review  

PEL Application & Maintenance:  

• Lead the preparation, submission, and defense of the PEL application to Swissmedic  

• Serve as the primary contact point for Swissmedic during inspections and communications  

• Ensure continuous compliance with license conditions and support renewals and variations as needed  

• Ensure authorised operations are conducted in compliance with the conditions of Swissmedic Establishment License for import incl. release to the market, wholesale, export, and trade in foreign countries, as well as with the License for Controlled Substances, and to Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01)  

Ensure temperature monitoring, excursion handling, and product integrity throughout the supply chain  

Inspection Readiness:  

• Prepare and lead Quality activities for the site for Swissmedic and/or EU inspections and audits  

• Coordinate and respond to inspection findings and ensure implementation of corrective actions  

Stakeholder Collaboration:  

• Liaise with internal departments (Regulatory Affairs, Supply Chain, Clinical) and external partners (contract manufacturers, distributors)  

• Provide regulatory guidance for local and EU pharmaceutical operations  

• Key contributor to the Global Quality management Review   

Profile 

• Experience in setting up pharmaceutical operations or start-up environments  

• Excellent organizational, communication, and problem-solving skills  

• Ability to work independently and manage multiple priorities  

• Strong cross-functional collaboration and ability to work effectively with IT, Business Owners, QA, and external vendors  

• Skilled in managing relationships across global teams (US, EU, Switzerland)  

• Strong written and verbal communication skills for presenting to executive stakeholders  

• Excellent troubleshooting skills to address complex quality issues  

• Aptitude for identifying inefficiencies and driving process improvements within QA frameworks  

• Meticulous review of documentation to ensure regulatory and quality robustness  

• Ability to mentor others in quality and best practices  

• Initiative in shaping compliance culture across the organization  

Qualifications 

• Swiss-recognized Qualified Person (QP) and/or Responsible Person (RP) per TPA and Swissmedic requirements  

• Degree in Pharmacy, Chemistry, Biology, or related field  

• Minimum of 8-10 years of experience in Quality Assurance within the pharmaceutical, biotechnology, or medical device industries with at least 5 years of experience in a Fachtechnisch verantwortliche Person (FvP) role within the pharmaceutical industry  

• Proven experience with Swissmedic regulations, PEL submissions, and GMP/GDP audits  

• Strong knowledge of Swiss and EU pharmaceutical legislation  

• Mentor cross-functional teams in Quality best practices while influencing executive decision-making through clear, data-driven communication and quality-driven leadership  

• Enthusiastic, highly motivated and a growth mindset  

• Positive attitude and flexible approach to work  

• Fluency in English and German required