Associate Director, Quality Change Management

Madrigal; Pennsylvania; Hybrid; USD 164,000 - 201,000; Full time

Benefits offered by this job

Equity

Flexible PTO

Health insurance

401(k) with employer match

Mental health benefits

Job summary

Madrigal is seeking a Change Control Governance lead to own the change control standards, templates, and readiness criteria across Quality, CMC, MSAT, and Supply Chain. You will partner with internal teams and external partners to ensure risk-based decisions, timely execution, and inspection-ready documentation.

The role requires 10–12 years GMP QA/QMS experience, strong leadership, and deep knowledge of eQMS systems such as Veeva Vault.

Qualifications

• BS+ in Science / Engineering (or related).
• Demonstrated ability to lead cross-functional governance and risk-based decision making.
• Experience with change control governance in pharma/biotech is a plus.

Responsibilities

• Own change control standards, templates, decision rights, and review cadences.
• Coordinate change reviews across Quality / CMC / MSAT / Supply Chain and external partners.

Skills

Cross-functional leadership

Risk-based decision making

Project management

Effective communication

Education

BS in Science / Engineering

Tools

Veeva Vault Quality (eQMS)

Job description

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.

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 Responsibilities

Change 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. We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact [e-mail].

• 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.
• 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.

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 other characteristic protected by applicable federal, state, or local law.

Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.

Join our growing team focused on transforming the treatment of people with liver diseases.

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 other characteristic protected by applicable federal, state, or local law.