Leads GCP quality oversight for global clinical program(s) to ensure sustained compliance, inspection readiness across internal teams. Implements standards for risk-based oversight, issue management rigor, translating quality signals into cross-functional actions that protect participants and data integrity. Oversees quality performance across a portfolio of programs and studies, ensuring measurable recurrence reduction. Provides executive-ready reporting on quality risks, trends, and readiness, and may lead/mentor GCP quality staff.

Key Responsibilities

Execution of Oversight Strategy & Key Clinical Vendor Quality Governance

• Implement GCP oversight standards and governance cadence (key vendor portfolio risk reviews, issue triage/escalation, readiness checkpoints) across global clinical programs.
• Manage quality to quality partnership with key clinical vendors, ensuring quality agreements/expectations, performance metrics, and corrective actions drive sustained improvement.
• Monitor emerging regulations, guidance documents, and industry best practices and assess impact to the overall quality management system.
• Produce deliverables such as program/study level Quality Risk Management Plans

Portfolio & Audit Management

• Drive systemic issue identification and cross-study actions based on trends (findings, deviations, CAPA performance, audit outcomes).
• Attend study team meetings to provide quality guidance and proactive risk assessment.
• Review key clinical and regulatory documents such as IBs, Protocols, Amendments, Informed Consent Forms, TMF Plans, submission documents.
• Develop and execute risk-based audit strategies and contribute to the annual GCP audit plan.
• Manage external audit partners and consultants from planning through closure activities.
• May lead and will oversee audits of clinical trial vendors, investigator sites, Documents/TMFs and internal processes.
• Provide support in and lead audit report reviews, track and follow-up on Findings and Observations
• Track and/or follow-up on Internal, Vendor/Site CAPAs, Quality Event investigations, deviations, potential serious breaches and misconduct investigations through to closure
• Analyze quality metrics and identify opportunities for process improvement and compliance enhancement.
• Act as a trusted quality advisor to R&D leadership and study teams to provide guidance to cross-functional stakeholders.
• Mentor and develop Quality team members.
• Support departmental strategic planning and resource prioritization activities.
• Produce deliverables such as Program level audit planning, quality management review metrics

Inspection Readiness & Quality Issue Escalation/Reporting

• Lead inspection readiness planning and execution for assigned or across programs, coordinating mock inspections, evidence readiness, and response governance as needed.
• Lead investigations and CAPA effectiveness across the portfolio.
• Produce deliverables such as inspection readiness activities or plans and audit/CAPA effectiveness summaries for management review.

Required Qualifications

• Minimum 10 years in clinical quality assurance
• Minimum 3 years experience in a clinical operations role at a CRO or Sponsor
• Demonstrated experience conducting and/or overseeing vendor, investigator site, Document/TMF, and process audits.

Preferred Qualifications

• BS+ in Life Sciences or related discipline.
• Experience leading global health authority inspection readiness and responses (e.g., FDA) across sponsor-led and outsourced models
• Experience implementing/optimizing eQMS workflows and quality metrics frameworks for GCP oversight at scale; Veeva Quality a plus

Key Competencies

• Strong working knowledge of ICH GCP, FDA, EMA, and global regulatory requirements. GVP and GLP a plus
• Clinical quality oversight governance, portfolio risk management, and standard setting across study teams and vendors.
• Executive-ready risk communication, escalation, and decision support, strong cross-functional leadership.
• Quality oversight of key clinical vendors (e.g., quality agreements, metrics, audits, remediation) .
• Skilled in developing collaborative internal and external relationships, ideally within a global organization; Ability to interact with all levels within a global organization
• Business and Operational acumen to include escalation to management

Madrigal's Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.

All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate's qualifications, skills, education, experience, business needs and market demands. As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $165,000 - $201,000 per year. We comply with all applicable minimum wage laws.

All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.

Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws.