Associate Director, Quality Change Management

Key Responsibilities

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 LIFE CYCLE 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.

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)

Total Rewards

• 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.
• 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.

Equal Opportunity Employer

We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact HR@madrigalpharma.com.

We are 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.