Senior Manager, GCP Quality Assurance

Position Summary

The GCP/Clinical Quality Assurance role focuses on ensuring compliance and quality of Madrigal-sponsored clinical trials with applicable GCP regulations, ICH GCP guidelines, Madrigal SOPs, and industry best practices. The incumbent reports to the Senior Director of GCP Quality.

• Develop, implement, and maintain clinical quality systems and processes to ensure compliance with ICH GCP, FDA, EMA, and other global regulatory requirements.
• Ensure R&D clinical trial activities are compliant with ICH and applicable country regulations, guidelines, and industry standards.
• Align the organization to ICH by implementing a quality culture from the outset of clinical trials to promote patient safety and data integrity.
• Apply a risk‑based approach in collaboration with cross‑functional teams to ensure compliance.
• Attend routine internal and external study team and ad‑hoc calls to support ongoing quality oversight.
• Inform and, when appropriate, elevate quality concerns to management in real time or during routine updates.
• Manage vendor and external partner quality, engaging partnership via quality agreements and routine meetings.
• Coordinate and manage services provided by external quality auditing partners (planning to closeout).
• Conduct and oversee internal and external audits (clinical trial vendor, site, TMF, document, internal process) and prepare or review audit reports.
• Manage quality events, CAPAs, and eQMS activities, including tracking and follow‑up on observations, CAPAs, investigations, deviations, and other quality events through closure.
• Lead quality investigations (QEs), including potential serious breach, fraud/misconduct, etc.
• Support the use of the eQMS via data entry and document upload of quality activities such as audits, findings, inspections, CAPAs, SOP deviations, and updates.
• Conduct or manage SOP reviews or updates and contribute to the annual audit plan.
• Review key clinical program or study documents (IBs, protocols/amendments, consents, TMF plans).
• Coordinate inspection readiness activities across R&D functions and support during global agency inspections.
• Execute other tasks in support of GCP/Clinical Quality activities, including departmental process improvements.
• Stay abreast of applicable global regulations, guidance, and industry best practices.
• Manage studies across compounds/therapeutic area programs.
• Provide mentorship to other team members, as applicable.

• Minimum 7 years of experience in clinical quality assurance within the biopharmaceutical or CRO industry, including auditing of clinical trial vendors, sites, TMFs, or internal R&D process audits.
• Minimum 3–5 years of experience in a clinical operations role at a CRO or sponsor, including management of a study at a cross‑functional level.
• Experience in inspection preparation and/or supporting health authority/regulatory agency inspections.
• Demonstrated GCP knowledge; GVP/GLP knowledge or certifications are a plus.
• BS in a scientific or other relevant discipline with equivalent work experience.

• Solid understanding of the cross‑functional drug development process and experience interacting with Operations, Data Management, Pharmacovigilance/Safety, Medical, Statistics/Programming, etc.
• Skilled in developing collaborative internal and external relationships, ideally within a global organization.
• Business and operational acumen, including escalation to management.
• Ability to interact with all levels within a global organization.
• Experience in using eQMS systems, such as Veeva.

Pay
: $147,000 – $180,000 per year (subject to market, experience, and business needs).

All full‑time employees receive equity and a comprehensive benefits suite including flexible paid time off, medical, dental, vision, life/disability insurance, 401(k) with employer match, and access to mental health resources.

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. 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 any other characteristic protected by applicable federal, state, or local law.