Job Description
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
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.
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:
Review manufacturing and quality records
Certify batch release for the Swiss Market or Export
Ensuring compliance with GMP and Swiss legal requirements (if applicable)
GMP and GDP Compliance:
Qualify / Audit and Manage third-party service providers (e.g., CMO, logistics, warehousing)
Oversee GDP-compliant distribution of medicinal products in Switzerland
Ensure temperature monitoring, excursion handling, and product integrity throughout the supply chain
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
Profile
Experience in setting up pharmaceutical operations or start-up environments
Excellent organizational, communication, and problem-solving skills
Ability to work independently and manage multiple priorities
Strong cross-functional collaboration and ability to work effectively with IT, Business Owners, QA, and external vendors
Skilled in managing relationships across global teams (US, EU, Switzerland)
Strong written and verbal communication skills for presenting to executive stakeholders
Excellent troubleshooting skills to address complex quality issues
Aptitude for identifying inefficiencies and driving process improvements within QA frameworks
Meticulous review of documentation to ensure regulatory and quality robustness
Ability to mentor others in quality and best practices
Initiative in shaping compliance culture across the organization
Qualifications
Swiss-recognized Qualified Person (QP) and/or Responsible Person (RP) per TPA and Swissmedic requirements
Degree in Pharmacy, Chemistry, Biology, or related field
Minimum 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 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
Fluency in English and German required
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.
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.
