Associate Director, API Quality Assurance (GMP)
Madrigal Pharmaceuticals
August 10, 2026
Remote friendly (United States)
United States
Operations
Key Responsibilities
- Own GMP API Quality Assurance strategy, governance cadence, and standards across external API manufacturers.
- Lead quality oversight of API and intermediate manufacturing at CMOs/CDMOs, ensuring ICH Q7 and global GMP compliance.
- Set expectations for API batch record review quality, documentation rigor, and decision rationale traceability.
- Drive deviation impact assessment, RCA rigor, CAPA linkage, and effectiveness verification for API quality events.
- Oversee change control review and approval for API processes, specifications, methods, and partner-initiated changes.
- Maintain quality agreements with API CMOs and lead performance governance routines (KPIs, scorecards, QBRs).
- Partner with MSAT/CMC on API control strategy evolution, validation readiness, and tech transfer to/from partners.
- Ensure quality oversight across the API lifecycle, including PPQ, routine manufacturing, and post-approval changes.
- Lead inspection readiness for API operations (documentation, evidence packages, audit response narratives).
- Support FDA/EMA and other health authority inspections related to API manufacturing and partner audits.
- Drive trending and recurrence prevention for API quality events; deliver management review-ready insights.
- Lead and mentor API QA staff and provide quality input on cross-functional governance forums.
Required Qualifications
- BS or MSc in a scientific discipline (Chemistry, Chemical Engineering, Pharmacy, or related).
- 10–12 years of GMP pharmaceutical/biotech experience focused on API quality and CMO oversight.
- Leadership in API batch disposition, deviation/CAPA, and change control governance.
- Strong knowledge of ICH Q7, ICH Q8–Q11, FDA, EMA, and global API regulatory expectations.
- Track record managing external API manufacturers and supporting health authority inspections.
Preferred Qualifications
- Advanced degree (MS/PhD) and experience with small molecule API and/or oligonucleotide manufacturing.
- Tech transfer, validation, and post-approval change management experience at API CMOs.
- Experience with Veeva Vault Quality (eQMS) and API quality metrics/trending.
- Experience in pharmaceutical/biotech external manufacturing networks.
Application Instructions
- Applications are being accepted on an ongoing basis through Madrigal Careers site.
- Own GMP API Quality Assurance strategy, governance cadence, and standards across external API manufacturers.
- Lead quality oversight of API and intermediate manufacturing at CMOs/CDMOs, ensuring ICH Q7 and global GMP compliance.
- Set expectations for API batch record review quality, documentation rigor, and decision rationale traceability.
- Drive deviation impact assessment, RCA rigor, CAPA linkage, and effectiveness verification for API quality events.
- Oversee change control review and approval for API processes, specifications, methods, and partner-initiated changes.
- Maintain quality agreements with API CMOs and lead performance governance routines (KPIs, scorecards, QBRs).
- Partner with MSAT/CMC on API control strategy evolution, validation readiness, and tech transfer to/from partners.
- Ensure quality oversight across the API lifecycle, including PPQ, routine manufacturing, and post-approval changes.
- Lead inspection readiness for API operations (documentation, evidence packages, audit response narratives).
- Support FDA/EMA and other health authority inspections related to API manufacturing and partner audits.
- Drive trending and recurrence prevention for API quality events; deliver management review-ready insights.
- Lead and mentor API QA staff and provide quality input on cross-functional governance forums.
Required Qualifications
- BS or MSc in a scientific discipline (Chemistry, Chemical Engineering, Pharmacy, or related).
- 10–12 years of GMP pharmaceutical/biotech experience focused on API quality and CMO oversight.
- Leadership in API batch disposition, deviation/CAPA, and change control governance.
- Strong knowledge of ICH Q7, ICH Q8–Q11, FDA, EMA, and global API regulatory expectations.
- Track record managing external API manufacturers and supporting health authority inspections.
Preferred Qualifications
- Advanced degree (MS/PhD) and experience with small molecule API and/or oligonucleotide manufacturing.
- Tech transfer, validation, and post-approval change management experience at API CMOs.
- Experience with Veeva Vault Quality (eQMS) and API quality metrics/trending.
- Experience in pharmaceutical/biotech external manufacturing networks.
Application Instructions
- Applications are being accepted on an ongoing basis through Madrigal Careers site.