Associate Director, GMP Quality Release (Quality API)

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.

Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.

Position Summary

Leads batch review and release operations across API and intermediate manufacturing, with additional support for drug product (DP) release as needed to ensure end-to-end disposition capability. Owns batch disposition standards, review quality, and cycle-time performance, ensuring consistent, compliant, and well-documented release decisions across the commercial portfolio.

Establishes review checklists, escalation pathways, and decision rights for routine and exception scenarios across API and DP modalities. Partners with external CMOs/CDMOs, MSAT, Supply Chain, and Regulatory to manage release priorities, resolve deviations, and protect supply continuity. While this role is primarily API-focused, the role is expected to maintain working DP release expertise to back up the broader Batch Review and Release team and provide coverage as needed. Maintains inspection readiness through robust documentation control, traceable rationales, and clear release narratives.

Key Responsibilities

• Own batch review and release standards, decision rights, and review checklists for API/intermediates, with DP cross-coverage capability
• Lead disposition of commercial API and intermediate batches; provide DP release support to assist team members as needed
• Drive cycle-time, backlog management, and right-first-time (RFT) performance across the API release workflow
• Establish escalation pathways for release exceptions, OOS/OOT results, and deviation-impacted batches
• Coordinate review and resolution of release-blocking deviations, investigations, and documentation gaps with CMOs/CDMOs
• Assess deviation and change impact on batch disposition and document risk-based release decisions with traceable rationale
• Own and govern the Batch Disposition process within Veeva, ensuring inspection-ready records and audit trail integrity
• Partner with MSAT, Supply Chain, and Regulatory on release priorities, supply continuity, and timeline mitigation
• Maintain inspection-ready release evidence packages; support SwissMedic, FDA, EMA, and other health authority inspections
• Drive trending and recurrence prevention for repeat documentation errors; partner with CMOs on RFT improvements
• Lead and mentor batch review and release staff and provide cross-coverage between API and DP release as required
• Contribute to SOPs, work instructions, and continuous improvement of release workflows across modalities

Required Qualifications

• BS or MSc in a scientific discipline (Chemistry, Chemical Engineering, Pharmacy, Life Sciences, or related)
• 10-12 years of GMP pharmaceutical/biotech experience including significant batch disposition/release leadership
• Demonstrated experience in API batch review and release with working knowledge of drug product release to support cross-coverage
• Strong knowledge of ICH Q7, ICH Q8-Q10, FDA, EMA, and global GMP batch release expectations
• Proven track record managing batch release at external CMOs and improving release cycle time

Preferred Qualifications

• Hands-on experience with both API and DP disposition workflows
• Experience with Veeva Vault Quality (eQMS) batch disposition module
• Experience supporting health authority inspections with batch disposition narratives and evidence packages
• Experience leading or mentoring batch release teams in a virtual/outsourced manufacturing model

Key Competencies

• Batch disposition governance, review quality standards, and cycle-time/backlog management
• Cross-modality release capability (API primary, DP cross-coverage) and team-wide coverage discipline
• Risk-based release judgment, deviation impact assessment, and escalation governance
• Partner governance and performance management across CMOs/CDMOs for release documentation quality
• Cross-functional leadership, escalation, and executive-ready risk / decision communication
• Inspection readiness documentation rigor, audit narrative development, and evidence retrieval readiness
• Right-first-time improvement, recurrence prevention, and continuous improvement delivery
• Veeva Vault Quality (eQMS) proficiency to govern Batch Disposition end-to-end with audit-ready traceability

We are committed to fostering an inclusive and diverse workplace and do not discriminate on the basis of any legally protected characteristics. Madrigal processes your personal data in connection with its recruitment and talent sourcing activities in accordance with applicable data protection laws. Further information about how your personal data is processed, together with details of your rights and how to exercise them, is available in our Job Applicant Privacy Notice, which is made available to you if you apply through Workday.

Please note that this job description is not exhaustive and may evolve over time. Only shortlisted candidates will be contacted. Applicants must be authorized to work in the country of employment at the time of application. Employment terms, where applicable, will be governed by relevant collective bargaining agreements.

Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.