Sr Manager Quality Assurance, International (RPQP)

Amsterdam - Netherlands

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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.

Madrigals 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.

TheSr Manager Quality Assurance International(RP/QP)will be leading and managingEuropean 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 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.

The Sr Manager EU QA willbe 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 Quality lead for EUGxPinspections including preparation management and follow-up of MIA and WDA inspections by national regulatory authorities (e.g. MHRA ANSMBfArM)

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

Lead the coordination and execution of 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-based Quality team 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

Oversee the WDA-compliant distribution activities ensuring proper control over warehousing transportation and documentation

Develop and implement quality assurance strategies aligned with evolving EU regulations and guidance

Provide QA oversight for third-party manufacturers importers and distributors in the EU region

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 EU Head of QA lead and manageGxPInspections on behalf of the company

Establish metrics and report the state of GMP Quality and compliance to VP of Quality

Lead and/or 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

Requirements

8 years of experience in Quality Assurance within the pharmaceutical biotechnology or medical device industry

BS MSc or PhD in a scientific discipline

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

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

Business-savvy with strong interpersonal negotiationpresentationand communication skills

Abilityabilityto manage and develop the quality functionwithin 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 MHRA 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

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

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 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

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 Madrigal Careers 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 Madrigals 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 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 .

Required Experience:

Manager