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Madrigal is focused on developing therapeutics to improve the lives of patients with metabolic and fatty liver diseases.
Associate Director, GLP Quality
Location
United States
Posted
44 days ago
Salary
$163K - $200K / year
Seniority
Lead
No structured requirement data.
Job Description
Associate Director, GLP Quality
Madrigal Pharmaceuticals
Role Description We are seeking an experienced Associate Director, GLP Quality to provide phase-appropriate quality oversight for non-clinical development activities across a growing portfolio of programs. This role requires strong knowledge of US and EU regulatory expectations, risk-based vendor oversight, and the ability to operate effectively in a virtual biotech environment with a global network of CROs, laboratories, consultants, and development partners. The Senior Manager will lead GLP quality oversight for regulated non-clinical studies and external partners, ensuring compliance, documentation integrity, and inspection readiness. This individual will drive audit strategy, issue management, CAPA effectiveness, and continuous improvement while partnering cross-functionally with Development, Regulatory, CMC, Technical Operations, Clinical, and external vendors to support progression of key programs (e.g., Investigational New Drug (IND) submissions). Key Responsibilities - GLP Oversight & Vendor Governance - 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. - Issue Management, Inspection Readiness & QMS Support - 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. - Cross-Functional Partnership - 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. Qualifications - 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. Preferred Qualifications - Experience supporting regulatory submissions and health authority inspections related to development programs. - Hands-on experience auditing and managing CROs, contract laboratories, and other GxP vendors supporting non-clinical programs. - Familiarity with Veeva and other electronic quality systems, audit management tools, and document management platforms used in virtual organizations. - Experience supporting cross-functional quality interfaces spanning non-clinical, CMC, and clinical development. - Experience in a mid-sized biotech with both commercial and development-stage assets. Key Competencies - Deep knowledge of non-clinical quality, GLP oversight, and vendor governance. - Strong risk assessment, decision-making, and problem-solving capability. - Inspection readiness and audit leadership with a focus on pragmatic, compliant execution. - Clear, concise communication and the ability to influence across internal teams and external partners. - Ability to thrive in a fast-paced, cross-functional, remote environment with high integrity and accountability. Benefits - Competitive Total Rewards strategy including base pay, bonus, equity, and a generous benefits package. - Base salary range: $163,000 - $200,000 per year. - Equity opportunities to reinforce ownership culture. - Comprehensive benefits including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings. - Voluntary benefits like supplemental life insurance, legal services, and mental health benefits through the Employee Assistance Program.
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