Madrigal Pharmaceuticals
Madrigal Pharmaceuticals is a biopharmaceutical company focused on developing novel therapeutics for nonalcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). The company achieved a significant milestone with the accelerated FDA approval of its first therapy for adults with NASH with moderate to advanced liver fibrosis. Madrigal is actively conducting a Phase 3 trial for the treatment of NASH with compensated cirrhosis. The company is dedicated to improving care for patients with NASH/MASH through its ambitious research programs and therapeutic developments.
Liver Disease β’ NASH β’ Metabolic Disease
51 - 200 employees
π Pharmaceuticals
𧬠Biotechnology
βοΈ Healthcare Insurance
π° $259M Post-IPO Equity on 2022-12
Manager - GCP Quality Assurance
March 18
πΊπΈ United States β Remote
β° Full Time
π‘ Mid-level
π Senior
π§ QA Engineer (Quality Assurance)
π¦ H1B Visa Sponsor
Madrigal Pharmaceuticals
Madrigal Pharmaceuticals is a biopharmaceutical company focused on developing novel therapeutics for nonalcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). The company achieved a significant milestone with the accelerated FDA approval of its first therapy for adults with NASH with moderate to advanced liver fibrosis. Madrigal is actively conducting a Phase 3 trial for the treatment of NASH with compensated cirrhosis. The company is dedicated to improving care for patients with NASH/MASH through its ambitious research programs and therapeutic developments.
Liver Disease β’ NASH β’ Metabolic Disease
51 - 200 employees
π Pharmaceuticals
𧬠Biotechnology
βοΈ Healthcare Insurance
π° $259M Post-IPO Equity on 2022-12
π Description
β’ Responsible for GCP/Clinical Quality Assurance activities. β’ 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. β’ Develop, implement, and maintain clinical quality systems and processes to ensure compliance with GCP, FDA, EMA, and other global regulatory requirements. β’ Ensure clinical trial activities are compliant with ICH and applicable country regulations and guidelines and industry standards. β’ Align organization to ICH in implementing a quality culture from the outset of clinical trials. β’ Apply a risk-based approach to ensure compliance. β’ Provide support during global agency inspections and participate in inspection readiness activities. β’ Coordinate reviews, manage documentation, and track internal Quality Event investigations.
π― Requirements
β’ Minimum of 5 years of experience in clinical quality assurance within the biopharmaceutical or CRO industry β’ Overall qualification by experience to support the responsibilities not limited to those outlined above β’ Demonstrated GCP knowledge, GLP/Nonclinical/GVP knowledge a plus β’ Solid understanding of the cross-functional drug development process, including specific to clinical trial functional operations, data management, statistics, etc. β’ Skilled in developing collaborative internal and external relationships β’ Business and Operational acumen to include escalation to management β’ Ability to interact with all levels within an organization β’ Experience in inspection preparation or supporting regulatory agency inspections β’ Experience in using eQMS systems, such as Veeva β’ BS in a scientific or other relevant discipline with equivalent work experience β’ Occasional travel for team meetings, audits, inspections etc.
ποΈ Benefits
β’ flexible paid time off (PTO) β’ medical β’ dental β’ vision β’ life and disability insurance
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