Manager, GCP Quality Assurance

Summary

Join Madrigal, a biopharmaceutical company focused on NASH therapeutics, as their Manager, GCP Quality Assurance. This remote position ensures quality and compliance of Madrigal-sponsored clinical trials, adhering to GCP regulations, ICH guidelines, and industry standards. You will develop and maintain clinical quality systems, ensure compliance with global regulatory requirements, and collaborate cross-functionally. The role involves managing quality events, conducting audits, reviewing documents, and supporting regulatory inspections. A minimum of 5 years of experience in clinical quality assurance within the biopharmaceutical or CRO industry is required. Competitive compensation includes base salary, bonus, equity, and comprehensive benefits.

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
• 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

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

Preferred Qualifications

Demonstrated GCP knowledge, GLP/Nonclinical/GVP knowledge a plus

Benefits

• Flexible paid time off (PTO)
• Medical
• Dental
• Vision
• Life and disability insurance
• Bonus
• Equity