About this role
About the Role The Associate Director, GMP Quality Release (Quality API) will lead the GMP quality release activities for Quality API at Madrigal. Based in Zug, Switzerland, this role ensures compliant and timely batch release and collaborates with QA, Manufacturing, and Regulatory teams to support the company’s MASH-focused pipeline. What You'll Do
- Lead GMP quality release activities for Quality API, ensuring timely and compliant batch release.
- Review and approve batch records, deviations, and CAPAs related to Quality API release.
- Collaborate with Quality, Manufacturing, and Regulatory teams to maintain release readiness and regulatory compliance.
- Support audit readiness and continuous improvement of release processes.
- Provide leadership and mentorship to the QA Release team. What We're Looking For
- Bachelor's degree in life sciences or a related field; advanced degree preferred.
- 8+ years' experience in GMP quality assurance, with a focus on API release; leadership experience ideal.
- Strong knowledge of GMP regulations (FDA, EMA) and quality systems related to API release.
- Excellent communication, cross-functional collaboration, and problem-solving skills.
- Willingness to work onsite in Zug, Switzerland; fluency in English; other languages a plus.