Owns deviation management governance to ensure deviations are triaged, investigated, and closed in a timely, compliant, and high-quality manner. Establishes standards for investigation rigor, root cause analysis, impact assessment, and linkage to CAPA and change control. Drives performance management (cycle time, backlog, aging) and trending to reduce recurrence and protect compliance and supply. Maintains inspection readiness through consistent documentation practices and governance routines across internal and external partners as applicable. Coaches teams on investigation quality expectations and effective prevention actions.

Key Responsibilities

Process Ownership & Governance

• Own deviation standards, templates, training expectations, and governance cadence (triage, backlog, aging, escalation)
• Ensure consistent severity classification and impact assessment expectations across teams / sites / partners
• Produce deliverables such as deviation governance playbooks, triage guides, and KPI dashboards

Investigation Quality & CAPA Linkage

• Drive RCA rigor and evidence standards, coach investigators and ensure high-quality conclusions and documentation
• Ensure CAPA linkage, effectiveness checks, and recurrence prevention are implemented and verified
• Produce deliverables such as investigation quality checklists, CAPA linkage reports, and effectiveness review summaries

Trending & Inspection Readiness

• Own deviation trending and management review inputs, identify systemic themes and drive cross-functional actions
• Maintain inspection-ready deviation records and process narratives, support audits / inspections and responses
• Produce deliverables such as trend reports, management review packs, and inspection-ready narratives

Required Qualifications

• BS+ in Science / Engineering (or related)
• 7-10 years in GMP QA / QMS with strong deviation / investigation leadership experience
• Demonstrated improvements in cycle time, investigation quality, and recurrence reduction

Preferred Qualifications

• Experience in pharmaceutical / biotech external manufacturing networks and partner deviation governance (preferred)
• Experience with eQMS workflows and continuous improvement / problem-solving facilitation

Key Competencies

• Deviation governance, investigation quality standards, and cycle-time / backlog management, escalation, and action closure discipline
• RCA facilitation, CAPA linkage, and effectiveness verification, recurrence prevention, and trending insights
• Partner governance and performance management across sites / CMOs for deviation quality and responsiveness (as applicable)
• Cross-functional leadership, escalation, and executive-ready risk / decision communication
• Inspection readiness documentation rigor, audit narrative development, and evidence retrieval readiness
• Veeva Vault Quality (eQMS) proficiency to drive deviation workflow execution, CAPA linkage, and trending

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 $147,600 - $180,400 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.