Manager Quality Assurance, EU Deputy Responsible Person

Position Summary

We areseekingan experienced and proactiveManager Quality Assurance Europe Responsible Personto support the companys European quality assurance activities with a strong focus on EU regulatory inspections MIA (Manufacturing and Importation Authorization)and WDA (Wholesale Distribution Authorization) compliance. The successful candidate will play a critical role in ensuringinspectionreadiness supporting the development and maintenance of a robust quality system and interacting with regulatory authorities and partners across the EU.

This is a unique opportunity to join the EU Quality team to activelyparticipatein building out the organization from potential EU launch and to play a key role as part of the broader EU team in the development of Madrigal in Europe.

TheManager Quality Assurance EuropeResponsible Personwillbe responsible forensuring quality assurance (QA) activities across the European Union (EU) remain in compliance with regulatory standards company policies and industry best practices.

The role requires ensuring product safety and efficacy andmaintainingcompliance with EU Good Manufacturing Practices (GMP) Good Clinical Practices (GCP) and Good Distribution Practices (GDP).

Key Responsibilities

• Provide support to the Associate Director QARPand Quality lead for EUGxPinspections including preparation management and follow-up of MIA and WDA inspections by national regulatory authorities (e.g. MHRA IGJ Swiss Medic)

• Maintain and enhance the EU Quality Management System to ensure continued compliance with EU GMP and GDP requirements

• support inspection readiness programs and mock inspections for EU-authorized facilities

• Assist US-based team in reviewing executed batch records for completeness accuracy and compliance

• Supporting or interfacing with Qualified Persons (QPs) tofacilitatecompliant batch certification and release under MIA

• Partner with US- and Swiss based Quality team EU RP/QPs manufacturing and supply chain teams to ensure readiness for product release and market supply

• Manage the quality aspects of importation and distribution activitiesin accordance withMIA/WDA requirements ensuring product traceability storage conditions and documentation meet EU GDP standards

• Support and oversee the WDA-compliant distribution activities ensuring proper control over warehousing transportation and documentation

• Support the implementation quality assurance strategies aligned with evolving EU regulations and guidance

• Conduct audits and review audit outcomes for continuous improvement and CAPA implementation

• Support regulatory submissions and responses related to EU quality and compliance matters

• Create andmaintainquality policies procedures and systems to ensure compliance with European regulatory requirements (e.g. EMA MHRA)

• Participate in inspections by regulatory bodies such as EMA and address any findings or corrective actions

• Collaborate with cross-functional teams including R&D Manufacturing and Supply Chain to ensure quality is integrated throughout the product lifecycle

• Support the EU leadership team in making risk-based decisionsregardingproduct quality and compliance

• Ensure that all EU suppliers and vendors meet the companys quality standards andcomply withEU regulations

• Operates as an effective liaison with external partners/contractors

• Develop and implement risk mitigation strategies to address potential compliance issues and operational disruptions

• Provides input to regulatory responses

• Participate in preparations for (corporate and third-party) inspection-readiness

• In conjunction with the Associate Director QA RP support the EU Head of QA lead and manageGxPInspections on behalf of the company

• Support inestablishmetrics and report the state of GMP/GDP Quality and compliance to Head of EU QA

• Support and oversee consultant mediated audits; develop and evaluate adequacy and completeness of CAPA plans including follow-up activities

• Provide consultation in interpretation of regulations/guidelines as they apply toGxPpractice awareness of regional regulatory requirement and phase of study

• Maintain required knowledge of applicable regulations guidelines and company standards and procedures

Qualifications

• Minimum of 5 years of experience in Quality Assurance within the pharmaceutical biotechnology or medical device industries

• BSc MSc or PhD in a scientific discipline

• ProvenexpertiseinEU GMP and GDP regulations particularly in relation toMIA and WDA requirements including Batch release

• Eligible to be registered as Responsible Person on Madrigals WDA

• The candidate should havea track recordof successful interaction with external suppliers strategic partners and regulatory agencies asdemonstratedbytimelydrug product supply submissions and approvals of biopharmaceutical products

• Extensive knowledge of EU regulatory requirements including GMP GDP and GCP

• This business-savvy leader will have strong leadership interpersonal negotiation presentation and communication skills and the ability to manage a quality culture within R&D Manufacturing Supply Chain and Commercial Operations.

• Strong knowledge and experience in leading the design development and/or reviews of QA standards and procedures (i.e. policy documents and SOPs)

• Knowledge andexpertisein principles and practice of current Good Manufacturing Practices (GMPs) from development through commercial applications

• Ability to make rationaltimely and compliant risk-based decisions

• Direct experience in managing FDA EMA MHRASwissmedicand other regulatory body inspections

• Skilled in developing collaborative internal and external relationships

• Excellent troubleshooting skills with the ability to solve complex problems

• Willingness to travel within Europe/US as needed

• Hybrid work schedule with in-office requirements and travel are

• Fluency in English is; fluency in Dutch/German would be highly beneficial andadditionalEuropean languages are a plus