Associate Director Quality Assurance; FvP

Position Summary

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction‑associated steatohepatitis (MASH). We are seeking an experienced Swiss‑medic‑recognized Fachtechnischverantwortliche Person (FvP) to establish a local pharmaceutical quality system in Switzerland and lead efforts to obtain and maintain a Pharmaceutical Establishment License (PEL). This role ensures compliance with Swiss and EU GMP/GDP requirements and supports local operations such as importation release distribution and oversight of pharmaceutical products.

• Design, implement, and maintain a fit‑for‑purpose Quality Management System (QMS) aligned with Swiss medic, EU GDP/GMP, and company global quality and compliance 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.
• Lead the preparation, submission, and defense of the PEL application to Swiss medic.
• Serve as the primary contact point for Swiss medic during inspections and communications.
• Ensure continuous compliance with license conditions and support renewals and variations as needed.
• Ensure authorized operations are conducted in compliance with Swiss medic Establishment License conditions for import, release, wholesale export, and trade in foreign countries, as well as with the License for Controlled Substances and the 2013/01 Guidelines on Good Distribution Practice of medicinal products for human use.
• Review manufacturing and quality records and certify batch release for the Swiss market or export.
• Qualify, audit, and manage third‑party service providers (e.g., CMO logistics warehousing) and oversee GDP‑compliant distribution of medicinal products in Switzerland.
• Monitor temperature excursions, handle product integrity throughout the supply chain, and implement corrective actions.
• Prepare and lead quality activities for Swiss medic and EU inspections and audits, coordinate findings, and ensure implementation of corrective actions.
• Liaise with internal departments (Regulatory Affairs, Supply Chain, Clinical) and external partners (contract manufacturers, distributors) to provide regulatory guidance for local and EU pharmaceutical operations and contribute to the Global Quality management Review.

• 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.

• Swiss‑recognized Qualified Person (QP) and/or Responsible Person (RP) per Swiss medic 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 in a Fachtechnischverantwortliche Person (FvP) role.
• Proven experience with Swiss medic 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.
• Enthusiastic, highly motivated, growth mindset with a positive attitude and flexible approach.
• Fluency in English and German.

All full‑time employees receive equity, flexible paid time off, medical, dental, vision, life/disability insurance, and 401(k) offerings with traditional Roth and employer match. Additional voluntary benefits include supplemental life insurance, legal services, mental health benefits through the Employee Assistance Program, and other benefits in accordance with applicable federal, state, and local laws.

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 any other characteristic protected by applicable federal, state, or local law.

Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site.