Madrigal Pharmaceuticals
Madrigal is focused on developing therapeutics to improve the lives of patients with metabolic and fatty liver diseases.
Liver Disease • NASH • Metabolic Disease
51 - 200
💰 $259M Post-IPO Equity on 2022-12
Manager, GCP Quality Assurance
April 24
Madrigal Pharmaceuticals
Madrigal is focused on developing therapeutics to improve the lives of patients with metabolic and fatty liver diseases.
Liver Disease • NASH • Metabolic Disease
51 - 200
💰 $259M Post-IPO Equity on 2022-12
Description
• 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 • Attend routine internal, external study team and ad hoc calls in support of ongoing quality oversight • Coordinate reviews, management documentation, track and/or follow-up on internal Quality Event investigations, deviations, Observations/Findings, CAPAs, etc. to ensure closure • Stay abreast of applicable global regulations, guidances, and industry best practices
Requirements
• Demonstrated GCP knowledge, GLP/GVP knowledge a plus • Solid understanding of the cross-functional drug development process • Skilled in developing collaborative internal and external relationships • Business and Operational acumen • Ability to interact with all levels within an organization • Experience in inspection preparation or supporting regulatory agency inspections • Experience in using eQMS systems • BS in a scientific or other relevant discipline with equivalent work experience
Benefits
• Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law. • Unsolicited resumes from agencies should not be forwarded to Madrigal. • Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.
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