Associate Director, Development Quality – OSD

Madrigal Pharmaceuticals; Waltham (MA); On-site; USD 169,000 - 198,000; Full time

Benefits offered by this job

Equity

Flexible PTO

Medical insurance

Dental insurance

Vision insurance

401(k) with match

Life/disability insurance

Mental health benefits

Employee Assistance Program

Job summary

Madrigal Pharmaceuticals is seeking a Senior Quality leader to own the quality strategy for oral development programs, ensuring phase-appropriate oversight and compliant execution across internal and external teams.

You will partner with CMC and clinical supply stakeholders on control strategies, tech transfer readiness, and issue management to enable efficient progression toward commercialization while maintaining compliance.

Qualifications

• BS+ Life Sciences / Engineering (or related)
• 10–12 years QA experience with development-stage oversight
• Demonstrated cross-functional leadership and risk-based judgment
• Experience in pharmaceutical / biotech oral product development and clinical supply interfaces (preferred)
• Experience with external development networks and inspection support

Responsibilities

• Own quality strategy, governance cadence, and risk register for assigned oral programs, define and track readiness milestones
• Guide application of QMS processes (deviations / CAPA / change control) in development context and ensure timely closure
• Produce deliverables such as program quality plans, readiness trackers, and decision / action logs
• Oversee external vendors / CMOs supporting oral development activities as applicable, ensure governance and escalation pathways
• Maintain inspection-ready documentation, narratives, and evidence packages for program scope
• Produce deliverables such as vendor governance packs, audit readiness checklists, and inspection evidence indexes

Skills

Cross-functional leadership

Risk assessment

Quality systems (QMS)

Education

BS Life Sciences / Engineering

Tools

Veeva Vault Quality (eQMS)

Job description

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.

Provides modality-focused development QA leadership for oral programs, ensuring phase-appropriate oversight, risk management, and compliant execution across internal teams and external partners. Owns program-level quality strategy, governance cadence, and readiness milestones and ensures development documentation is traceable and inspection-ready. Partners with CMC and clinical supply stakeholders on control strategy evolution, tech transfer readiness, and issue management. Supports efficient progression toward commercialization while maintaining compliance and predictable execution.

Key Responsibilities

• Own quality strategy, governance cadence, and risk register for assigned oral programs, define and track readiness milestones
• Guide application of QMS processes (deviations / CAPA / change control) in development context and ensure timely closure
• Produce deliverables such as program quality plans, readiness trackers, and decision / action logs

Partner Oversight & Inspection Readiness

• Oversee external vendors / CMOs supporting oral development activities as applicable, ensure governance and escalation pathways
• Maintain inspection-ready documentation, narratives, and evidence packages for program scope
• Produce deliverables such as vendor governance packs, audit readiness checklists, and inspection evidence indexes

Required Qualifications

• BS+ Life Sciences / Engineering (or related)
• 10–12 years QA experience with development-stage oversight
• Demonstrated cross-functional leadership and risk-based judgment

Preferred Qualifications

• Experience in pharmaceutical / biotech oral product development and clinical supply interfaces (preferred)
• Experience with external development networks and inspection support

Key Competencies

• Development QA governance, phase-appropriate oversight, and readiness milestone management for oral programs
• Change management (impact assessment, stakeholder mapping, communications, training / SOP readiness, adoption measurement)
• Partner governance and performance management across CMOs / vendors, inspection readiness evidence discipline
• Cross-functional leadership, escalation, and executive-ready risk / decision communication
• Quality risk management, issue triage, and timely action closure across development stakeholders
• Veeva Vault Quality (eQMS) proficiency to track program quality events, vendor oversight and readiness documentation

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. 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 $168,737 - $198,073 per year. We comply with all applicable minimum wage laws.

All 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 [e-mail].

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.

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: 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 [e-mail].