Leads Quality change control governance to ensure changes are risk-assessed, compliant, and implemented with appropriate controls across internal operations and external partners. Establishes predictable, high-quality change execution by aligning stakeholders on impact assessment, readiness criteria, and documentation expectations. Partners with CMC / MSAT, Supply Chain, Operations, and Quality teams to enable tech transfers, validation readiness, and lifecycle changes. Owns change performance metrics (cycle time, aging, quality) and drives continuous improvement of the change process. Ensures inspection-ready traceability from change initiation through closure.
Key ResponsibilitiesChange Control Governance & Standards- Own change control standards, templates, decision rights, and review cadences, ensure consistent risk-based assessments
- Define implementation readiness criteria, verification expectations, and closure quality standards
- Produce deliverables such as change control playbooks, review checklists, and readiness / verification templates
Cross-Functional & Partner Alignment- Coordinate change reviews across Quality / CMC / MSAT / Supply Chain and external partners, align timelines and dependencies
- Escalate high-risk or supply-impacting changes with options, mitigation plans, and decision points
- Produce deliverables such as cross-functional change review packs, decision logs, and dependency trackers
Performance Management & Inspection Readiness- Own change KPIs and continuous improvement actions, drive predictable throughput without compromising quality
- Ensure inspection-ready change documentation, traceability, and evidence retrieval
- Produce deliverables such as KPI dashboards, aging / backlog reports, and inspection-ready change narratives
Required Qualifications- BS+ in Science / Engineering (or related)
- 10-12 years GMP QA / QMS with change control leadership experience
- Demonstrated ability to lead cross-functional governance and risk-based decision making
Preferred Qualifications- Experience in pharmaceutical / biotech post-approval change governance and external manufacturing changes (preferred)
- Experience with eQMS configuration and workflow optimization
Key Competencies - Change control governance, risk-based impact assessment, and implementation readiness criteria, predictable throughput management
- Cross-functional leadership, escalation, and executive-ready risk / decision communication
- Change management (stakeholder mapping, communications, training / SOP readiness, adoption measurement) for change process discipline
- Partner governance and performance management across sites / CMOs for change execution quality and timeliness
- Inspection readiness traceability, documentation rigor, and effectiveness / verification discipline
- Veeva Vault Quality (eQMS) proficiency to manage change controls end-to-end (risk, approvals, traceability, closure)
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 $164,000 - $200,750 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.
