Manager Quality Assurance, EU Deputy Responsible Person

Position Summary 

We are seeking an experienced and proactive Manager Quality Assurance – Europe Responsible Person to support the company’s 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 ensuring inspection readiness, 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 actively participate in 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.   

The Manager Quality Assurance – Europe Responsible Person will be responsible for ensuring 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 and maintaining compliance with EU Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Distribution Practices (GDP). 

Key Responsibilities 

• Provide support to the Associate Director QA, RP and Quality lead for EU GxP inspections, 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) to facilitate compliant 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 activities in accordance with MIA/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 and maintain quality 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 decisions regarding product quality and compliance 

• Ensure that all EU suppliers and vendors meet the company's quality standards and comply with EU 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 manage GxP Inspections on behalf of the company  

• Support in establish metrics 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 to GxP practice, 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  

• Proven expertise in EU GMP and GDP regulations, particularly in relation to MIA and WDA requirements including Batch release 

• Eligible to be registered as Responsible Person on Madrigal’s WDA 

• The candidate should have a track record of successful interaction with external suppliers, strategic partners, and regulatory agencies, as demonstrated by timely drug 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 and expertise in principles and practice of current Good Manufacturing Practices (GMPs) from development through commercial applications 

• Ability to make rational, timely, and compliant risk-based decisions 

• Direct experience in managing FDA, EMA, MHRA, Swissmedic and 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 required 

• Fluency in English is required; fluency in Dutch/German would be highly beneficial, and additional European languages are a plus