Associate Director, GLP Quality

Madrigal is seeking an experienced Associate Director, GLP Quality to oversee non-clinical development activities, ensuring compliance and quality in a virtual biotech environment. The role involves vendor oversight, audit strategy, issue management, and cross-functional collaboration to support regulatory submissions and program progression.

Location: Remote (US)

Salary: $163,000 - $200,000 per year

Responsibilities

• Lead quality oversight of non-clinical studies conducted at CROs, contract laboratories, bioanalytical laboratories, toxicology sites, and other external partners supporting development programs
• Develop and maintain a risk-based vendor oversight model, including qualification, onboarding, performance monitoring, audits, issue escalation, and periodic review
• Plan, conduct, and manage GxP audits; drive timely closure of findings and CAPAs with effectiveness verification
• Review study- and vendor-related quality documentation, including protocols, reports, deviations, CAPAs, change controls, quality agreements, and data integrity concerns, as applicable
• Lead investigations, root cause analysis, and CAPA activities associated with non-clinical quality events and vendor performance issues, including trending and recurrence prevention
• Maintain inspection readiness for non-clinical activities through controlled documentation, evidence packages, and support for regulatory inspections, partner audits, and due diligence reviews
• Provide guidance and training to internal teams and external partners to reinforce GLP expectations, documentation discipline, and quality standards
• Contribute to the design, implementation, and continuous improvement of phase-appropriate QMS processes relevant to non-clinical development in a virtual company model
• Provide quality input to governance forums, program teams, and functional leadership on compliance risks, mitigation strategies, and business impact
• Partner with Regulatory Affairs to support quality aspects of IND, CTA, IMPD, NDA/BLA/MAA, or related submissions
• Collaborate across Development, CMC, Technical Operations, and Clinical to ensure quality interfaces are managed effectively across development programs
• Support the build-out of scalable quality infrastructure and mentor junior team members as needed

Requirements

• BS in Life Sciences or related discipline; advanced degree preferred
• 10+ years of GLP QA or non-clinical quality experience, including audit and vendor oversight responsibilities
• Strong knowledge of applicable US and EU regulatory requirements for non-clinical development and GLP-regulated activities
• Demonstrated experience overseeing outsourced activities in a virtual or highly outsourced biotech or pharmaceutical environment
• Strong risk-based judgment, documentation integrity, and issue management capability

Benefits

• Competitive Total Rewards including base pay, bonus, equity, and comprehensive benefits package such as flexible paid time off, medical, dental, vision, life/disability insurance, 401(k), voluntary benefits, mental health support, and more.

Additional Information

• Base salary is estimated between $163,000 - $200,000 per year, depending on qualifications and experience.
• Full-time employees are eligible for equity, benefits, and other perks.
• Madrigal is committed to diversity and inclusion, providing accommodations for individuals with disabilities.
• Applications are accepted on an ongoing basis through the Madrigal Careers site.
• Beware of fraudulent recruitment scams impersonating Madrigal.