Job 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.
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 Quality
Requirements
- Experience and Professional Qualifications
- The successful candidate for the position of Head of EU Quality Operations will be the following:
- Minimum of 10 years of experience in Quality Assurance within the pharmaceutical, biotechnology, or medical device industries
- BS, MSc, or PhD in a scientific discipline
- Extensive knowledge of EU and Swiss GxP regulatory requirements (GMP, GDP, GCP)
- Demonstrated experience managing regulatory inspections (SwissMedic, EMA, MHRA, etc.)
- Proven leadership and ability to influence in matrixed environments.
- Expertise in developing and implementing QA standards, SOPs, and policies.
- Business acumen and ability to partner cross-functionally (R&D, Manufacturing, Supply Chain, Commercial).
- 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) and Good Distribution (GDP) practice
- Ability to make rational, timely, and compliant risk-based decisions
- Skilled in developing collaborative internal and external relationships
- Excellent troubleshooting skills with the ability to solve complex problems
- Fluency in English is required; fluency in German would be highly beneficial, and additional European languages are a plus
Other Requirements
· Willingness to travel within Europe and occasionally to the U.S.
· Hybrid working schedule (in-office presence required periodically
We are committed to fostering an inclusive and diverse workplace and do not discriminate on the basis of any legally protected characteristics. Madrigal processes your personal data in connection with its recruitment and talent sourcing activities in accordance with applicable data protection laws. Further information about how your personal data is processed, together with details of your rights and how to exercise them, is available in our Job Applicant Privacy Notice, which is made available to you if you apply through Workday.
Please note that this job description is not exhaustive and may evolve over time. Only shortlisted candidates will be contacted. Applicants must be authorized to work in the country of employment at the time of application. Employment terms, where applicable, will be governed by relevant collective bargaining agreements.
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.
