Senior Manager / Associate Director Quality Assurance FVP

Position: Sr Manager / AD Quality Assurance / Fachtechnisch verantwortliche Person (FvP)Location: Zug, SwitzerlandThe OpportunityAbout 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).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.This position reports into the Head of EU Quality, and will be fully integrated in the Global QA Team.KEY RESPONSIBILITIESQuality 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 standardsDraft, review, and approve SOPs, policies, and related quality documentationDefine quality metrics and processes for internal audits, deviations, CAPA, change control, and management reviewPEL Application & Maintenance:Lead the preparation, submission, and defense of the PEL application to SwissmedicServe as the primary contact point for Swissmedic during inspections and communicationsEnsure continuous compliance with license conditions and support renewals and variations as neededEnsure 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 marketDistribution & GDP Compliance (RP):Oversee GDP-compliant distribution of medicinal products in SwitzerlandQualify and manage third-party service providers (e.g., logistics, warehousing)Ensure temperature monitoring, excursion handling, and product integrity throughout the supply chainInspection Readiness:Prepare and lead Quality activities for the site for Swissmedic and/or EU inspections and auditsCoordinate and respond to inspection findings and ensure implementation of corrective actionsStakeholder Collaboration:Liaise with internal departments (Regulatory Affairs, Supply Chain, Clinical) and external partners (contract manufacturers, distributors)Provide regulatory guidance for local and EU pharmaceutical operationsKey contributor to the Global Quality management ReviewPROFESSIONAL EXPERIENCE & QUALIFICATIONSSwiss-recognized Qualified Person (QP) and/or Responsible Person (RP) per TPA and Swissmedic requirementsDegree in Pharmacy, Chemistry, Biology, or related fieldPlease note that fluency in English and German is requiredMinimum of 8-10 years of experience in Quality Assurance within the pharmaceutical, biotechnology, or medical device industries with at least 5 years of experience in a Fachtechnisch verantwortliche Person (FvP) role within the pharmaceutical industryProven experience with Swissmedic regulations, PEL submissions, and GMP/GDP auditsStrong knowledge of Swiss and EU pharmaceutical legislationMentor cross-functional teams in Quality best practices while influencing executive decision-making through clear, data-driven communication and quality-driven leadershipEnthusiastic, highly motivated and a growth mindsetPositive attitude and flexible approach to workAdditional InformationMadrigal 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.