Associate Director, Quality Assurance - Deputy FvP

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.

The Deputy Fachtechnisch Verantwortliche Person (FvP) supports ongoing compliance with Swiss medic requirements and applicable EU GMP/GDP expectations under the Swiss Pharmaceutical Establishment License (PEL). Acting as the designated operational backup to the FvP, the deputy ensures continuity of quality system execution, inspection readiness, and day‑to‑day quality oversight of GMP/GDP activities, while also providing oversight of API manufacturing quality activities across the global supply network.

• Swiss Quality System, PEL & Swiss medic Interface
  - Support the implementation and maintenance of the Swiss QMS in alignment with Swiss medic, EU GMP/GDP, and global standards.
  - Contribute to preparation, maintenance, and inspection readiness of the Swiss Pharmaceutical Establishment License (PEL), including controlled documentation and evidence availability.
  - Support Swiss medic interactions (inspections, correspondence) as delegated, including timely coordination of requests and response drafting.
  - Produce deliverables such as PEL support documentation packs, QMS evidence indexes, and inspection correspondence trackers.
• Operational GMP/GDP Oversight & Release
  - Support batch certification/release activities as delegated by the FvP.
  - Review manufacturing, testing, and distribution documentation for GMP/GDP compliance globally for API supply and export finish goods, identifying gaps requiring correction or escalation.
  - Monitor GDP‑compliant distribution operations (3PL oversight, warehousing/transport conditions, temperature monitoring and excursion management).
  - Support issue management and escalation across internal and external stakeholders.
• API Manufacturing Oversight & Supplier Onboarding
  - Ensure quality activities associated with onboarding and qualification of new API manufacturing partners.
  - Oversee external API manufacturers and key suppliers across the global network, including technical transfers, validation activities, manufacturing readiness, and launch preparedness.
  - Drive quality risk management activities related to API manufacturing and supply continuity.
  - Monitor supplier performance, inspection outcomes, deviations, CAPAs, and change controls; support supplier governance processes and long‑term manufacturing network strategy.
  - Partner with CMC and Supply Chain to ensure continuity of global API supply.
• Inspection Readiness, Audits, CAPA & Delegated Coverage
  - Support regulatory inspections and internal/external audits.
  - Drive CAPA implementation, effectiveness checks, and inspection readiness activities.
  - Act as FvP delegate during approved absences within the scope authorized by Swiss medic.
  - Collaborate with Regulatory Affairs, Supply Chain, CMC, Clinical, CMOs, distributors, and service providers to provide operational quality input to supply and regulatory decisions.

• BS+ in Pharmacy, Chemistry, Biology (or related field)
• 10–12 years of pharmaceutical Quality Assurance experience with Swiss/EU GMP/GDP exposure and quality system execution experience
• Demonstrated experience overseeing API manufacturing operations, CMOs/CDMOs, and supplier quality management
• Eligible to act as Deputy FvP per Swiss medic requirements (FvP recognition preferred), with demonstrated inspection readiness support, documentation rigor, and cross‑functional coordination
• Fluent in German and English
• Strong knowledge of EU GMP, Swiss medic requirements, supplier quality management, and quality risk management
• Experience overseeing GDP distribution partners (e.g., 3PLs), including temperature monitoring and excursion…