Associate Director Quality Assurance; FvP

Position: Associate Director Quality Assurance (FvP)
Location: Indiana

We areseekingan experienced and Swiss medic-recognized

Fachtechnischverantwortliche

Person (FvP) to support the establishment of alocal pharmaceutical quality systemin Switzerland and lead the company’s efforts to obtain andmaintaina

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
** Design, implement, andmaintainafit-for-purpose Quality Management System (QMS) aligned with Swiss medic, EU GDP/GMP, and company global

Quality and Compliance processes and standards

Ensuring compliance with GMP and Swiss legal requirements (if applicable) 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 Strong written and verbal communication skills for presenting to executive stakeholders Excellent troubleshooting skills to address complex quality issues Ability to mentor others in quality and best practices
** Qualifications
* * Swiss-recognized Qualified Person (QP) and/or Responsible Person (RP) per TPA andSwissmedicrequirements

Minimum of8-10 years of experience in Quality Assurance within the pharmaceutical, biotechnology, or medical device industries with at least5 years of experience in aFachtechnischverantwortliche

Person (FvP) role within the pharmaceutical industry

Proven experience with Swissmedicregulations, PEL submissions, and GMP/GDP audits

Strong knowledge of Swiss and EU pharmaceutical legislation ## Join our growing team focused on transforming the treatment of people with liver diseases.

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.
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