Manager, GCP Quality Assurance

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ABOUT MADRIGAL: Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis. ROLE OVERVIEW: Manager, GCP Quality Assurance 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. This is a remote position. POSITION RESPONSIBILITIES: - Develop, implement, and maintain clinical quality systems and processes to ensure compliance with GCP, FDA, EMA, and other global regulatory requirements - Ensure clinical trial activities are compliant with ICH and applicable country regulations and guidelines and industry standards - 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, external study team and ad hoc calls in support of ongoing quality oversight - Inform and escalate to management in real-time or during routine updates, as appropriate - Engage partnership with external vendors via adherence to Quality Agreements and routine meetings - Coordinate reviews, management documentation, track and/or follow-up on internal Quality Event investigations, deviations, Observations/Findings, CAPAs, etc. to ensure closure - Support the use of an eQMS via data entry/document upload of quality activities (audits, observations, inspections, CAPAs, SOP Deviations, QEs/Investigations) and SOP updates - Contribute to the annual audit plan and Quality Management Reviews - Assure through Qualification audits and oversight activities that clinical trial vendors are operating in compliance with all applicable procedures, study documents, regulations/guidelines - May review vendor MSA or contract/Work Orders - Conduct or manage internal/external audits (vendor, site, document, system or process) and prepare or review audit reports - Coordinate and manage services provided by external QA vendors - Review key documents, such as IBs, Protocols/Amendments, Consents, TMF Plans - Participate in inspection readiness activities or provide support during global agency inspections - Conduct other tasks in support of GCP Quality activities - Stay abreast of applicable global regulations, guidance's, and industry best practices QUALIFICATIONS AND SKILLS REQUIRED: - Minimum of 5 years of experience in clinical quality assurance within the biopharmaceutical or CRO industry - Overall qualification by experience to support the responsibilities not limited to those outlined above - Demonstrated GCP knowledge, GLP/Nonclinical/GVP knowledge a plus - Solid understanding of the cross-functional drug development process, including specific to clinical trial functional operations, data management, statistics, etc. - Skilled in developing collaborative internal and external relationships - Business and Operational acumen to include escalation to management - Ability to interact with all levels within an organization - Experience in inspection preparation or supporting regulatory agency inspections - Experience in using eQMS systems, such as Veeva - BS in a scientific or other relevant discipline with equivalent work experience - Occasional travel for team meetings, audits, inspections etc. COMPENSATION: Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.