Associate Director, GLP Quality

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.

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

Required 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

Madrigal offers a competitive Total Rewards strategy to attract and retain top talent and is inclusive of base pay, bonus, equity, and a generous benefits package. Full-time employees are eligible for base salary, bonus, equity, and a comprehensive benefits suite.

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 $163,000 - $200,000 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. 

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. 

Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site. 

Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.  

Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for or on behalf of Madrigal, we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to HR@madrigalpharma.com.