Swiss QA Director & FvP Compliance Leader

Position Summary

Serves as the Swissmedic-recognized Fachtechnisch verantwortliche Person (FvP) and sole named responsible person on the company’s Swiss license, accountable for establishing a robust local Swiss Quality System and for leading the acquisition and ongoing maintenance of the Pharmaceutical Establishment License (PEL). Ensures end-to-end compliance with Swiss and EU GMP/GDP and enables local licensed operations (as applicable) including importation, batch certification/release, distribution oversight, and product control. Acts as a critical interface between global manufacturing operations and the company’s broader corporate and financial structure, actively shaping the operating and control model that underpins the Switzerland-based IP framework, including support for IP establishment/transfer and the legal/operational substance required for Switzerland to act as IP holder. Ensures manufacturing oversight, quality governance, and supply chain controls remain aligned to the conditions necessary to sustain the Swiss entity’s role, and influences decisions on manufacturing footprint, governance model, and quality system design to protect the integrity, defensibility, and continuity of the IP structure. Concurrently retains global quality oversight and governance for API manufacturing, with particular emphasis on uninterrupted US API supply, leveraging internal and external resources for execution while maintaining ultimate FvP accountability and decision authority on Swiss QMS design, compliance strategy, and batch certification (as applicable).

Key Responsibilities

• Design, implement, and maintain the Swiss QMS aligned with Swissmedic, EU GMP/GDP, and global Quality/Compliance standards.
• Lead PEL strategy and execution: Prepare, submit, defend, and maintain the Swiss Pharmaceutical Establishment License (including renewals/variations).
• Serve as primary Swissmedic contact for inspections, correspondence, and regulatory interactions; ensure timely, accurate responses and commitments.
• Ensure all authorized activities are performed in compliance with PEL conditions and applicable Swiss regulatory requirements.
• Provide global quality oversight and governance for API manufacturing activities, ensuring appropriate control, compliance, and continuity of supply.
• Perform and/or oversee batch certification/release activities as applicable under Swiss/EU requirements; ensure compliant, inspection-ready release decisions.
• Review and approve key manufacturing/testing/distribution documentation required to support Swiss and/or EU market supply.
• Oversee GDP-compliant distribution in Switzerland, including qualification and governance of 3PL/warehousing providers.
• Ensure temperature monitoring, excursion handling, deviation management, and product integrity controls across the end‑to‑end supply chain.
• Lead inspection readiness and audit execution (Swissmedic and other relevant bodies), including findings responses, CAPA implementation, and effectiveness verification.
• Provide strategic quality/regulatory guidance to internal stakeholders (RA, Supply Chain, Tech Ops, Clinical) and external partners (CMOs, distributors).
• Influence manufacturing footprint, operating/control model decisions, and quality system design to sustain the Swiss operating model and IP structure requirements.

Required & Desired Qualifications

• Swiss-recognized FVP (and QP/RP as applicable).
• BS+ in Pharmacy, Chemistry, Biology, Engineering, or related scientific discipline.
• 12–15 years in pharmaceutical QA, including FVP experience with at least 5 years of experience as FvP role.
• Strong experience with Swissmedic, GMP/GDP, and PEL processes and GMP/GDP audits with fluency in German and English required.
• Experience standing up a Swiss QMS and securing/maintaining a Swiss PEL in a lean/local affiliate or virtual operating model (preferred).
• Global API manufacturing oversight experience across external networks (CMOs/testing sites), including supply continuity risk management.

Key Competencies

• FvP-level decision-making and accountability, Swissmedic inspection leadership, and regulatory authority interaction excellence.
• Swiss/EU GMP/GDP mastery with strong judgment on release, deviations, excursions, and product integrity risk.
• QMS design and governance (CAPA effectiveness, change control, documentation control) with inspection-ready evidence discipline.
• Global API quality governance, external manufacturing oversight, and supply continuity risk management.
• Strategic cross‑functional influence and stakeholder management in matrix organizations (internal and external partners).
• Ability to translate operating model / IP structure requirements into practical quality controls, oversight routines, and defensible compliance narratives.

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