Senior Manager / Associate Director Quality Assurance FVP
The Opportunity
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.
About Madrigal
Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction‑associated steatohepatitis (MASH), a liver disease with high unmet medical need. Madrigal’s medication is a once‑daily, oral, liver‑directed THR‑β agonist designed to target key underlying causes of MASH. This is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating our medication for the treatment of compensated MASH cirrhosis (F4c).
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)
Batch Release & Oversight :
* Act as the QP for product release, ensuring compliance with GMP and Swiss legal requirements (if applicable)
* Review manufacturing and quality records and certify batch release for the Swiss and/or EU market
Distribution & GDP Compliance (RP):
* Oversee GDP‑compliant distribution of medicinal products in Switzerland
* Qualify and manage third‑party service providers (e.g., logistics, warehousing)
* 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
Professional Experience & Qualifications
* Swiss‑recognized Qualified Person (QP) and/or Responsible Person (RP) per TPA and Swissmedic requirements
* Degree in Pharmacy, Chemistry, Biology, or related field
* Fluency in English and German is required
* Minimum of 8‑10 years of experience in Quality Assurance within the pharmaceutical, biotechnology, or medical device industries with at least 5 years in a 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
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
Additional Information
Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.
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