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. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). 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.<div></div><div>The Sr Manager, Quality Assurance International (RP/QP) will be leading and managing European quality assurance activities, with 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. </div><div>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. </div><div>The Sr Manager EU QA 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. </div><div>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). </div><div> </div><div>Key Responsibilities </div><div><div><ul><li>Provide support to the Quality lead for EU GxP inspections, including preparation, management, and follow-up of MIA and WDA inspections by national regulatory authorities (e.g., MHRA, ANSM, BfArM) </li></ul></div><div><ul><li>Maintain and enhance the EU Quality Management System to ensure continued compliance with EU GMP and GDP requirements </li></ul></div><div><ul><li>Lead the coordination and execution of inspection readiness programs and mock inspections for EU-authorized facilities </li></ul></div><div><ul><li>Assist US-based team in reviewing executed batch records for completeness, accuracy, and compliance </li></ul></div><div><ul><li>Supporting or interfacing with Qualified Persons (QPs) to facilitate compliant batch certification and release under MIA </li></ul></div><div><ul><li>Partner with US-based Quality team, RP/QPs, manufacturing, and supply chain teams to ensure readiness for product release and market supply </li></ul></div><div><ul><li>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 </li></ul></div><div><ul><li>Oversee the WDA-compliant distribution activities, ensuring proper control over warehousing, transportation, and documentation </li></ul></div><div><ul><li>Develop and implement quality assurance strategies aligned with evolving EU regulations and guidance </li></ul></div><div><ul><li>Provide QA oversight for third-party manufacturers, importers, and distributors in the EU region </li></ul></div><div><ul><li>Conduct audits and review audit outcomes for continuous improvement and CAPA implementation </li></ul></div><div><ul><li>Support regulatory submissions and responses related to EU quality and compliance matters </li></ul></div><div><ul><li>Create and maintain quality policies, procedures, and systems to ensure compliance with European regulatory requirements (e.g., EMA, MHRA) </li></ul></div><div> </div><div><ul><li>Participate in inspections by regulatory bodies, such as EMA, and address any findings or corrective actions </li></ul></div><div><ul><li>Collaborate with cross-functional teams, including R&D, Manufacturing, and Supply Chain, to ensure quality is integrated throughout the product lifecycle </li></ul></div><div><ul><li>Support the EU leadership team in making risk-based decisions regarding product quality and compliance </li></ul></div><div><ul><li>Ensure that all EU suppliers and vendors meet the company's quality standards and comply with EU regulations </li></ul></div><div><ul><li>Operates as an effective liaison with external partners/contractors </li></ul></div><div><ul><li>Develop and implement risk mitigation strategies to address potential compliance issues and operational disruptions </li></ul></div><div><ul><li>Provides input to regulatory responses </li></ul></div><div><ul><li>Participate in preparations for (corporate and third-party) inspection-readiness </li></ul></div><div><ul><li>In conjunction with the EU Head of QA, lead and manage GxP Inspections on behalf of the company </li></ul></div><div><ul><li>Establish metrics and report the state of GMP Quality and compliance to VP of Quality </li></ul></div><div><ul><li>Lead and/or oversee consultant mediated audits; develop and evaluate adequacy and completeness of CAPA plans including follow-up activities </li></ul></div><div><ul><li>Provide consultation in interpretation of regulations/guidelines, as they apply to GxP practice, awareness of regional regulatory requirement, and phase of study </li></ul></div><div><ul><li>Maintain required knowledge of applicable regulations, guidelines, and company standards and procedures </li></ul></div><div> </div><div>Requirements </div><div><ul><li>8+ years of experience in Quality Assurance within the pharmaceutical, biotechnology, or medical device industry </li></ul></div><div><ul><li>BS, MSc, or PhD in a scientific discipline </li></ul></div><div><ul><li>Proven expertise in EU GMP and GDP regulations, particularly in relation to MIA and WDA requirements including Batch release </li></ul></div><div><ul><li>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 </li></ul></div><div><ul><li>Extensive knowledge of EU regulatory requirements, including GMP, GDP, and GCP </li></ul></div><div><ul><li>Business-savvy, with strong interpersonal, negotiation, presentation and communication skills </li></ul></div><div><ul><li>Abilityability to manage and develop the quality function within R&D, Manufacturing, Supply Chain, and Commercial Operations. </li></ul></div><div><ul><li>Strong knowledge and experience in leading the design, development, and/or reviews of QA standards and procedures (i.e., policy documents and SOPs) </li></ul></div><div><ul><li>Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs) from development through commercial applications </li></ul></div><div><ul><li>Ability to make rational, timely, and compliant risk-based decisions </li></ul></div><div><ul><li>Direct experience in managing FDA, EMA, MHRA, and other regulatory body inspections </li></ul></div><div><ul><li>Skilled in developing collaborative internal and external relationships </li></ul></div><div><ul><li>Excellent troubleshooting skills with the ability to solve complex problems </li></ul></div><div><ul><li>Willingness to travel within Europe/US as needed </li></ul></div><div><ul><li>Hybrid work schedule with in-office requirements and travel are required </li></ul></div><div><ul><li>Fluency in English is required; fluency in German would be highly beneficial, and additional European languages are a plus </li></ul></div></div>All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization. Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws. We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact HR@madrigalpharma.com. Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law. 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. Applications are being accepted on an ongoing basis and can be submitted through our <a target="_blank" href="https://madrigalpharma.wd501.myworkdayjobs.com/Madrigal">Madrigal Careers</a> site. Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for or on behalf of Madrigal, we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to <a target="_blank" href="mailto:HR@madrigalpharma.com">HR@madrigalpharma.com</a>.

Sr Manager Quality Assurance, International (RP/QP)

Description

Madrigal Pharmaceuticals

Pipeline