Director Quality Assurance - FvP

5w1 month ago

Madrigal Pharmaceuticals

Zug, CH · Full-time · CHF 200,000 – CHF 280,000

About this role

Madrigal Pharmaceuticals 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, and premature mortality. Every member of our team is connected by our shared purpose: leading the fight against MASH.

In this role, you will serve as the Swissmedic-recognized Fachtechnisch verantwortliche Person (FvP) and sole named responsible person on the company's Swiss license. You will be accountable for establishing a robust local Swiss Quality System and leading the acquisition and ongoing maintenance of the Pharmaceutical Establishment License (PEL).

You will act 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. This includes support for IP establishment and transfer, as well as the legal and operational substance required for Switzerland to act as IP holder.

Concurrently, you will retain global quality oversight and governance for API manufacturing, with particular emphasis on uninterrupted US API supply. You will leverage internal and external resources for execution while maintaining ultimate FvP accountability and decision authority on Swiss QMS design, compliance strategy, and batch certification.

Requirements

Recognized as Fachtechnisch verantwortliche Person (FvP) by Swissmedic or eligible for such recognition
Deep expertise in Swiss and EU GMP/GDP requirements for pharmaceutical manufacturing and distribution
Proven experience leading Pharmaceutical Establishment License (PEL) acquisition, maintenance, and defense
Strong background in quality system design, implementation, and management within a biopharmaceutical environment
Experience with batch certification/release processes under Swiss and EU regulatory frameworks
Demonstrated ability to interface with regulatory authorities, particularly Swissmedic, during inspections and correspondence
Knowledge of IP structuring and the operational substance requirements for a Swiss-based IP holding entity
Experience providing global quality oversight for API manufacturing, including supply continuity management

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 and variations
Serve as primary Swissmedic contact for inspections, correspondence, and regulatory interactions; ensure timely, accurate responses and commitments
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
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
Influence decisions on manufacturing footprint, governance model, and quality system design to protect the integrity, defensibility, and continuity of the IP structure

Benefits

Opportunity to lead the Swiss quality system for a pioneering MASH therapeutics company
High-impact role as the sole named responsible person on the Swiss license
Collaborative, dynamic, and inclusive culture that values scientific excellence and operational rigor
Influence over global manufacturing footprint and quality governance decisions