Associate Director, GLP Quality
Madrigal Pharmaceuticals
June 30, 2026
Remote friendly (Conshohocken, PA)
United States
Operations
Key Responsibilities
GLP Oversight & Vendor Governance
- Lead quality oversight of non-clinical studies at CROs, contract/bioanalytical/toxicology labs, and other external partners.
- Develop/maintain a risk-based vendor oversight model (qualification, onboarding, performance monitoring, audits, issue escalation, periodic review).
- Plan, conduct, and manage GxP audits; ensure timely closure of findings and CAPAs with effectiveness verification.
- Review study- and vendor-related quality documentation (protocols, reports, deviations, CAPAs, change controls, quality agreements, and data integrity concerns, as applicable).
Issue Management, Inspection Readiness & QMS Support
- Lead investigations, root cause analysis, and CAPA activities for non-clinical quality events/vendor performance issues, including trending and recurrence prevention.
- Maintain inspection readiness using controlled documentation/evidence packages for regulatory inspections and partner audits/due diligence.
- Provide guidance and training to teams and partners on GLP expectations and documentation discipline.
- Contribute to design/implementation/continuous improvement of phase-appropriate QMS processes for non-clinical development in a virtual company model.
Cross-Functional Partnership
- Provide quality input to governance forums and program leadership on compliance risks, mitigation, and business impact.
- Partner with Regulatory Affairs on quality aspects of IND, CTA, IMPD, NDA/BLA/MAA (or related submissions).
- Collaborate across Development, CMC, Technical Operations, and Clinical to manage quality interfaces.
- Support scalable quality infrastructure build-out and mentor junior team members.
Required Qualifications
- BS in Life Sciences or related discipline; advanced degree preferred.
- 10+ years GLP QA or non-clinical quality experience, including audit and vendor oversight.
- Strong knowledge of applicable US/EU regulatory requirements for non-clinical development/GLP.
- Demonstrated experience overseeing outsourced activities in a virtual/highly outsourced biotech/pharma environment.
- Strong risk-based judgment, documentation integrity, and issue management.
Preferred Qualifications
- Experience with regulatory submissions and health authority inspections.
- Hands-on auditing/management of CROs and GxP vendors for non-clinical programs.
- Familiarity with Veeva and electronic quality/audit/document management tools.
- Experience across quality interfaces spanning non-clinical, CMC, and clinical.
- Experience in a mid-sized biotech with both commercial and development-stage assets.
Benefits
- Full-time employees: base pay, bonus, equity, and comprehensive benefits (flexible paid time off, medical/dental/vision, life/disability, and 401(k)).
Application Instructions
- Submit applications on an ongoing basis through the Madrigal Careers site.
GLP Oversight & Vendor Governance
- Lead quality oversight of non-clinical studies at CROs, contract/bioanalytical/toxicology labs, and other external partners.
- Develop/maintain a risk-based vendor oversight model (qualification, onboarding, performance monitoring, audits, issue escalation, periodic review).
- Plan, conduct, and manage GxP audits; ensure timely closure of findings and CAPAs with effectiveness verification.
- Review study- and vendor-related quality documentation (protocols, reports, deviations, CAPAs, change controls, quality agreements, and data integrity concerns, as applicable).
Issue Management, Inspection Readiness & QMS Support
- Lead investigations, root cause analysis, and CAPA activities for non-clinical quality events/vendor performance issues, including trending and recurrence prevention.
- Maintain inspection readiness using controlled documentation/evidence packages for regulatory inspections and partner audits/due diligence.
- Provide guidance and training to teams and partners on GLP expectations and documentation discipline.
- Contribute to design/implementation/continuous improvement of phase-appropriate QMS processes for non-clinical development in a virtual company model.
Cross-Functional Partnership
- Provide quality input to governance forums and program leadership on compliance risks, mitigation, and business impact.
- Partner with Regulatory Affairs on quality aspects of IND, CTA, IMPD, NDA/BLA/MAA (or related submissions).
- Collaborate across Development, CMC, Technical Operations, and Clinical to manage quality interfaces.
- Support scalable quality infrastructure build-out and mentor junior team members.
Required Qualifications
- BS in Life Sciences or related discipline; advanced degree preferred.
- 10+ years GLP QA or non-clinical quality experience, including audit and vendor oversight.
- Strong knowledge of applicable US/EU regulatory requirements for non-clinical development/GLP.
- Demonstrated experience overseeing outsourced activities in a virtual/highly outsourced biotech/pharma environment.
- Strong risk-based judgment, documentation integrity, and issue management.
Preferred Qualifications
- Experience with regulatory submissions and health authority inspections.
- Hands-on auditing/management of CROs and GxP vendors for non-clinical programs.
- Familiarity with Veeva and electronic quality/audit/document management tools.
- Experience across quality interfaces spanning non-clinical, CMC, and clinical.
- Experience in a mid-sized biotech with both commercial and development-stage assets.
Benefits
- Full-time employees: base pay, bonus, equity, and comprehensive benefits (flexible paid time off, medical/dental/vision, life/disability, and 401(k)).
Application Instructions
- Submit applications on an ongoing basis through the Madrigal Careers site.