Senior Manager, GCP Quality Assurance

Madrigal Pharmaceuticals

21h

About The Position

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.

Requirements

Minimum 7 years of experience in clinical quality assurance within the biopharmaceutical or CRO industry, to include auditing of clinical trial vendors, sites and/or TMFs or internal R&D process audits
Minimum 3-5 years of experience in a clinical operations role at a CRO or Sponsor, to include management of a study at a cross-functional level
Demonstrated GCP knowledge
BS in a scientific or other relevant discipline with equivalent work experience
Solid understanding of the cross-functional drug development process, including experience interacting with Operations, Data Management, Pharmacovigilance/Safety, Medical, Statistics/Programming, etc.
Skilled in developing collaborative internal and external relationships, ideally within a global organization
Business and Operational acumen to include escalation to management
Ability to interact with all levels within a global organization
Experience in using eQMS systems, such as Veeva

Nice To Haves

Experience in inspection preparation and/or supporting health authority/regulatory agency inspections a plus
GVP/GLP knowledge or certifications a plus

Responsibilities

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
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
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
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
Conduct or lead other tasks in support of GCP/Clinical Quality activities, including departmental process improvements
Stay abreast of applicable global regulations, guidance’s, and industry best practices
May manage studies across compounds/therapeutic area programs
Provide mentorship to other team members, as applicable