We areseekingan experienced andSwissmedic-recognizedFachtechnischverantwortlichePerson (FvP)to support the establishment of alocal pharmaceutical quality systemin Switzerland and lead the company’s efforts to obtain andmaintainaPharmaceutical Establishment License (PEL). This role is critical in ensuring compliance withSwiss and EU GMP/GDPrequirements 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 withSwissmedic, EU GDP/GMP, and company globalQuality and Compliance processes and standardsEnsuring 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 forpresenting 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 andSwissmedicrequirementsMinimum of8-10 years of experience in Quality Assurance within the pharmaceutical, biotechnology, or medical device industrieswith at least5 years of experience in aFachtechnischverantwortlichePerson (FvP)role within the pharmaceutical industryProven experience withSwissmedicregulations, PEL submissions, and GMP/GDP auditsStrong 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.
#J-18808-Ljbffr
#J-18808-Ljbffr