Manager, GMP API Quality Release

Job description

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. Executes GMP batch disposition and release for active pharmaceutical ingredients (APIs) and intermediates to ensure timely, compliant, well-documented release decisions supporting commercial supply. Reviews and dispositions API batch records, CofAs, and supporting quality documentation from external CMOs/CDMOs against approved specifications and the Quality Management System. Coordinates resolution of release-blocking deviations, OOS/OOT investigations, and documentation gaps with manufacturing partners and internal stakeholders. Maintains accurate, inspection-ready release records and contributes to cycle-time and right-first-time improvements for the API release workflow. Operates with documentation rigor, traceable decision rationales, and clear escalation discipline. Key Responsibilities Review and disposition GMP batch records, CofAs, executed batch documentation, and release packages for API and intermediates Verify conformance to approved specifications, methods, control strategy, and the Quality Management System Coordinate timely resolution of release-blocking deviations, OOS/OOT results, and documentation gaps with CMOs/CDMOs Assess impact of deviations and quality events on API batch disposition and document risk-based release decisions Own and execute the API Batch Disposition workflow within Veeva, ensuring complete and inspection-ready records Track and report API release cycle time, backlog, and RFT metrics; drive right-first-time improvements with partners Partner with MSAT, Supply Chain, and Regulatory on release priorities, supply continuity, and timeline mitigation Support change controls impacting API release (specifications, methods, supplier changes) with timely assessment Maintain inspection-ready release evidence packages and support audit/inspection responses for API operations Escalate quality concerns, recurring documentation errors, or supply-impacting risks with clear options and rationale Contribute to SOPs, work instructions, and release checklists for API disposition processes Support continuous improvement of release workflows and partner documentation quality Required Qualifications BS in a scientific discipline (Chemistry, Chemical Engineering, Pharmacy, Life Sciences, or related) 5-7 years of GMP pharmaceutical/biotech experience including hands-on batch record review and disposition Demonstrated experience reviewing API or drug product batch documentation from external CMOs Strong knowledge of GMP requirements, ICH Q7, and FDA/EMA expectations for batch release Strong documentation discipline, attention to detail, and risk-based judgment Preferred Qualifications Experience with API and intermediate disposition, including small molecule and/or oligonucleotide manufacturing Experience with Veeva Vault Quality (eQMS) batch disposition workflow Experience supporting health authority inspections with batch disposition narratives and evidence Experience reviewing deviation and OOS/OOT investigations Key Competencies Batch record review and disposition discipline, documentation rigor, and decision rationale traceability Risk-based judgment for release decisions, deviation impact assessment, and escalation discipline Partner coordination with external CMOs for documentation quality and timely issue resolution Cycle-time and right-first-time focus, backlog management, and metrics-driven execution Inspection readiness mindset, evidence retrieval readiness, and audit narrative support Cross-functional coordination across MSAT, Supply Chain, and Regulatory for release priorities Veeva Vault Quality (eQMS) proficiency to execute batch disposition workflows and maintain inspection-ready records 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.