Stellen

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 ensuretimely compliant well-documented release decisions supporting commercial supply. Reviews and dispositions API batch recordsCofAs 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. Maintainsaccurate 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 recordsCofAs executed batch documentation and release packages for API and intermediates

Verify conformance to approved specifications methods control strategy and the Quality Management System

Coordinatetimelyresolution 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 controlsimpactingAPI release (specifications methods supplier changes) withtimelyassessment

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 andtimelyissue 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)proficiencyto execute batch disposition workflows andmaintaininspection-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.

Required Experience:

Manager

Employment Type : Full-Time

Experience: years

Vacancy: 1