Manager - GCP Quality Assurance

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March 18

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Madrigal Pharmaceuticals

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Pharmaceuticals • Biotechnology • Healthcare Insurance

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.

51 - 200 employees

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

💰 $259M Post-IPO Equity on 2022-12

📋 Description

• Responsible for GCP/Clinical Quality Assurance activities. • 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. • 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. • Apply a risk-based approach to ensure compliance. • Provide support during global agency inspections and participate in inspection readiness activities. • Coordinate reviews, manage documentation, and track internal Quality Event investigations.

🎯 Requirements

• 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.

🏖️ Benefits

• flexible paid time off (PTO) • medical • dental • vision • life and disability insurance