Quality Compliance Lead International at Madrigal Pharmaceuticals

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.We are seeking an experienced and proactive Sr Manager / Associate Director of Quality Assurance to provide proactive GxP compliance oversight, facilitation and support to the European and International teams.Reporting to the Head of EU Quality Assurance, this role drives quality and compliance culture through implementation of harmonized standards at EU head quarter and EU, UK and Swiss affiliates, monitoring of key compliance activities and management reporting.Key Responsibilities• Support Inspection Readiness, Inspection Management, Compliance Remediation and Health Authority reporting (inspectional responses, complaint investigations, recall investigations, change control processing, PQRs) in partnership with Affiliates Quality Heads• Act as training coordinator for the European and international teams• Drive quality mind-set, harmonization of practices and continuous improvement in collaboration with US QA team• Assure periodic quality system reviews and management reporting (KPis, Complaints, training, etc.). including benchmarking, as needed, to the Quality Management Review• Facilitates Quality Governance process• Leads or participates in Quality projects upon request of Head of EU QAe.g. Harmonization projects, Implementation of QA processes and tools, Steering Committees• Provide compliance input to escalated issues regarding potential impacts to product QualityRequirements<ul><li>Experience and Professional Qualifications</li><li>The successful candidate for the position of Head of EU Quality Operations will be the following:</li><li>Minimum of 10 years of experience in Quality Assurance within the pharmaceutical, biotechnology, or medical device industries</li><li>BS, MSc, or PhD in a scientific discipline</li><li>Extensive knowledge of EU and Swiss GxP regulatory requirements (GMP, GDP, GCP)</li><li>Demonstrated experience managing regulatory inspections (SwissMedic, EMA, MHRA, etc.)</li><li>Proven leadership and ability to influence in matrixed environments.</li><li>Expertise in developing and implementing QA standards, SOPs, and policies.</li><li>Business acumen and ability to partner cross-functionally (R&D, Manufacturing, Supply Chain, Commercial).</li><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><li>§Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs) and Good Distribution (GDP) practice</li><li>Ability to make rational, timely, and compliant risk-based decisions</li><li>Skilled in developing collaborative internal and external relationships</li><li>Excellent troubleshooting skills with the ability to solve complex problems</li><li>Fluency in English is required; fluency in German would be highly beneficial, and additional European languages are a plus</li></ul>Other Requirements· Willingness to travel within Europe and occasionally to the U.S.· Hybrid working schedule (in-office presence required periodicallyAll 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>.

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Quality Compliance Lead International

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Madrigal Pharmaceuticals

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