Executive Director, Development Quality Lead
Key Responsibilities
Provides phase-appropriate Quality Assurance leadership for development activities, embedding quality planning and risk management into development execution.
Establishes governance for development quality oversight and ensures development documentation is traceable, controlled, and inspection ready.
PARTNERS WITH CMC AND CLINICAL SUPPLY STAKEHOLDERS ON CONTROL STRATEGY EVOLUTION, READINESS MILESTONES, AND TECH TRANSFER / SCALE-UP PLANNING.
GUIDES THE APPLICATION OF QMS PROCESSES (DEVIATIONS, CAPA, CHANGE CONTROL) IN DEVELOPMENT CONTEXTS AND SUPPORTS EFFICIENT PROGRESSION TOWARD COMMERCIALIZATION.
OVERSEES DEVELOPMENT PARTNERS / VENDORS AS APPLICABLE AND DRIVES ISSUE RESOLUTION AND COMPLIANCE READINESS.
Required Qualifications
- BS+ (Life Science, Engineering, or related)
- 18+ years QA (development / tech ops preferred) with governance and audit support experience
- Demonstrated cross-functional leadership and risk-based judgment
Preferred Qualifications
- Experience in pharmaceutical / biotech development quality and supporting development inspections / submission readiness (preferred)
- Experience overseeing CRO / CMO development partners
Key Competencies
- Development QA governance, phase-appropriate oversight, and readiness milestone management, documentation traceability discipline
- Quality risk management and decision support, deviation / CAPA / change control application in development context
- Partner / vendor oversight and audit readiness planning, issue escalation and follow-through across external networks
- Cross-functional leadership, escalation, and executive-ready risk / decision communication
- Control strategy evolution partnering with CMC and clinical supply, tech transfer / scale-up readiness alignment
- Veeva Vault Quality (eQMS) proficiency to manage development QMS records and inspection-ready traceability
Total Rewards
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 and offers meaningful opportunity for our employees to share in the success they help create. 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 $276,800 - $338,300 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 HR@madrigalpharma.com.
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.
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Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site.
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