Senior Manager, GCP Quality Assurance

Position Summary:
- Responsible for GCP/Clinical Quality Assurance activities to ensure quality and compliance of Madrigal-sponsored clinical trials with applicable GCP regulations, ICH GCP guidelines, Madrigal SOPs, and industry standards/best practices.
- Reports into the Senior Director, GCP Quality.

Key Responsibilities:
Strategy, Compliance and Oversight
- May develop/implement/maintain clinical quality systems and processes to ensure compliance with ICH GCP, FDA, EMA and other global requirements.
- Ensure R&D clinical trial activities are compliant with ICH, applicable country regulations, guidelines, and industry best practices.
- Implement a quality culture from the outset to promote patient safety and data integrity.
- Use a risk-based approach via cross-functional collaboration.
- Attend routine internal/external clinical study team calls and ad hoc calls; inform/escalate issues to management.
Vendor and External Partner Quality Management
- Partner with external clinical trial vendors via Quality Agreements and routine meetings; may review Quality Agreements.
- Onboard/coordinate/manage external quality auditing partners.
- Assure vendor compliance through qualification audits/oversight.
- Review CDAs, MSAs, and contract/work orders.
- Conduct/manage internal/external audits (vendor, site, TMF, documents, internal processes) and prepare/review audit reports.
Quality Events, CAPAs, and eQMS Management
- Lead reviews; manage documentation; track/follow up Observations/Findings, CAPAs, quality events/investigations, and deviations to closure.
- May lead quality investigations (e.g., Serious Breach, Fraud/Misconduct).
- Use eQMS for data entry/document upload of quality activities.
- Perform/manage SOP reviews/updates; contribute to annual audit plan; provide metrics for Quality Management Reviews.
Clinical Documentation and Process Improvement
- Review key clinical documents (IBs, protocols/amendments, consents, TMF plans).
- Support inspection readiness across R&D; support global agency inspections.
- Support GCP/Clinical Quality tasks and departmental process improvements; stay abreast of global regulations/guidance/best practices.
- May manage studies across compounds/therapeutic area programs; provide mentorship as applicable.

Preferred Qualifications:
- 7+ years in clinical quality assurance in biopharma or CRO (auditing vendors/sites/TMFs or internal R&D process audits).
- 3–5 years in clinical operations at a CRO or Sponsor (cross-functional study management).
- Experience with inspection preparation and/or supporting health authority inspections (plus).
- Demonstrated GCP knowledge; GVP/GLP knowledge/certifications (plus).
- BS in scientific or relevant discipline with equivalent work experience.

Key Competencies:
- Understanding of cross-functional drug development; experience interacting with Operations, Data Management, Pharmacovigilance/Safety, Medical, Statistics/Programming, etc.
- Build collaborative internal/external relationships in global organizations.
- Business/operational acumen and ability to escalate.
- Interact with all levels in global organization.
- Experience with eQMS systems (e.g., Veeva).