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.
Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra 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 Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).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 Fachtechnischverantwortliche 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 ControlledSubstances, 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)
- OverseeGDP-compliant distributionof 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 Fachtechnischverantwortliche 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
All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization. Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans.
We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws. We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact HR@madrigalpharma.com. 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. Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site. Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates.
Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners.
We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for or on behalf of Madrigal, we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to HR@madrigalpharma.com.
