Manager, GMP Quality Release

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.

The Manager QA supports the oversight of GDP and GMP/GDP-related quality activities for drug product and finished product distribution within Europe and International markets. The role supports the QA / EU International RP in maintaining compliance with applicable GDP requirements including oversight of 3PLs wholesalers distributors transport storage Quality Agreements audits deviations complaints returns recalls change controls CAPAs and inspection readiness.

The role acts as a key quality partner for Supply Chain Regulatory Affairs Quality Operations external logistics providers and other internal/external stakeholders to ensure compliant distribution activities inspection-ready documentation and continuous improvement of the EU/International Quality Management System.

Key Responsibilities

Batch Disposition & Release Oversight

• Support review and disposition of commercial batch records release packages CoAs and supporting GDP/GMP documentation across drug product and finished product
• Support documentation and coordination of release decisions ensuring they are well documented and aligned to approved specifications control strategy and QMS requirements
• Support release workflow execution standards cycle-time expectations and escalation of release-blocking issues impacting supply
• Support QA oversight of 3PLs wholesalers distributors and other GDP-relevant service providers.
• Support review and maintenance of Quality Agreements with 3PLs wholesalers distributors and other external partners.
• Support qualification and ongoing oversight of GDP vendors including review of licences audit outcomes quality performance and CAPA follow-up.
• Support oversight of storage transportation temperature excursions returned goods recalls and destruction activities as applicable.
• Support RP activities where appropriate including preparation of information for RP review/decision-making while ensuring RP responsibilities remain with the appointed RP.

Partner Quality & Quality Event Management

• Provide quality oversight of external manufacturers/3PLs including documentation quality governance and performance trending
• Support timely resolution of release-blocking complaints returns recalls deviations OOS/OOT results change controls and documentation gaps with 3PLs/CMOs/CDMOs and internal stakeholders

• Assess quality event impact on batch disposition and ensure decisions rationales and follow-up actions are clearly documented

• Support maintenance and continuous improvement of EU/International GDP procedures work instructions templates and training materials.

Inspection Readiness & Continuous Improvement

• Support preparation management and follow-up of GDP audits self-inspections and health authority inspections.
• Maintain inspection-ready release records evidence packages and disposition narratives to support audits and health authority inspections
• Drive right-first-time improvements backlog reduction and cycle-time performance across release processes and partner interfaces
• Partner cross-functionally with MSAT Supply Chain Regulatory and Quality Operations to mitigate supply risk and improve release predictability

Required Qualifications

• BS in a scientific discipline such as Chemistry Pharmacy Life Sciences or Engineering
• 58 years of GMP and GDP pharmaceutical/biotech experience with strong batch disposition release or QA operations experience
• Demonstrated experience reviewing batch documentation and managing quality events for external manufacturers supporting commercial products
• Experience with pharmaceutical distribution 3PL oversight wholesaler/distributor qualification Quality Agreements audits deviations CAPAs complaints returns or recalls.

Preferred Qualifications

• Experience with drug product and finished product batch release in external mfg networks
• Experience with Veeva Vault Quality / QMS release workflows and inspection-ready documentation practices
• Experience supporting FDA EMA or other health authority inspections including inspection readiness evidence retrieval and response preparation.

Key Competencies

• GDP distribution quality oversight including 3PL wholesaler/distributor oversight Quality Agreements and vendor qualification
• GMP/GDP documentation review and release support where applicable
• Quality event management including deviations complaints returns recalls change controls and CAPAs
• Inspection readiness cross-functional coordination evidence retrieval and issue escalation

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.