Director Quality Assurance - FvP
madrigalpharma · Zug - Switzerland - Office ·
- Category
- QA
- Experience
- 5+ years
Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.
Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.
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
Swiss Quality System, PEL & Swissmedic Interface
- 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
Operational GMP/GDP Oversight & Release Accountability
- 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
Global API Quality Governance & Strategic Cross-Functional Leadership
- Provide global quality oversight and governance for API manufacturing to ensure control, regulatory compliance, and continuity of supply (including US-market supply focus as applicable)
- 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
We are committed to fostering an inclusive and diverse workplace and do not discriminate on the basis of any legally protected characteristics. Madrigal processes your personal data in connection with its recruitment and talent sourcing activities in accordance with applicable data protection laws. Further information about how your personal data is processed, together with details of your rights and how to exercise them, is available in our Job Applicant Privacy Notice, which is made available to you if you apply through Workday.
Please note that this job description is not exhaustive and may evolve over time. Only shortlisted candidates will be contacted. Applicants must be authorized to work in the country of employment at the time of application. Employment terms, where applicable, will be governed by relevant collective bargaining agreements.
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