Senior Manager, GCP Quality Assurance
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.
Position Summary
This position will be responsible for GCP/Clinical Quality Assurance activities. The primary responsibilities will be to ensure quality and compliance of Madrigal-sponsored clinical trials with applicable GCP regulations, ICH GCP guidelines, Madrigal SOPs, and current industry standards and best practices. This position reports into the Senior Director, GCP Quality
Key Responsibilities
Strategy, Compliance and Oversight
- May develop, implement, and/or maintain clinical quality systems and processes to ensure compliance with ICH GCP, FDA, EMA, and other global regulatory requirements
- Ensure R&D clinical trial activities are compliant with ICH and applicable country regulations and guidelines and industry standards and best practices
- Align organization to ICH in implementing a quality culture from the outset of clinical trials to promote patient safety and data integrity
- Apply a risk-based approach by working collaboratively cross-functionally to ensure compliance
- Attend routine internal and external clinical study team and ad hoc calls in support of ongoing quality oversight
- Inform and escalate to management in real-time and/or during routine updates, as appropriate
Vendor and External Partner Quality Management
- Engage partnership with external clinical trial vendors via adherence to Quality Agreements and routine meetings; may review Quality Agreements
- Onboard, coordinate and/or manage services provided by external quality auditing partners (planning to closeout)
- Assure through Qualification audits and oversight activities that clinical trial vendors are operating in compliance with all applicable procedures, study documents, regulations/guidelines
- Review CDAs, MSAs or contract/Work Orders
- Conduct or manage internal/external audits (clinical trial vendor, site, TMF, document, internal process) and prepare or review audit reports
Quality Events, CAPAs, and eQMS Management
- Lead reviews, manage documentation, track and/or follow-up on Observations/Findings, CAPAs, Quality Event investigations, deviations, etc. through to closure
- May lead quality investigations (QEs), including potential Serious Breach, Fraud/Misconduct, etc.
- Support use of the eQMS via data entry/document upload of quality activities (audits, Findings/Observations and responses, inspections, CAPAs, SOP Deviations and updates, QEs/Investigations)
- Perform/manage SOP reviews or updates, contribute to the annual audit plan and provide input (including metrics) to prepare for Quality Management Reviews
Clinical Documentation and Process Improvement
- Review key clinical program or study documents, such as IBs, Protocols/Amendments, Consents, TMF Plans
- May coordinate or manage inspection readiness activities across R&D functions; provide support during global agency inspections
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