Associate Director, API Quality Assurance (GMP)

Madrigal Pharmaceuticals, Inc.; United States; On-site; USD 169,000 - 198,000; Full time

Benefits offered by this job

Equity / stock options

Flexible PTO

401(k) with match

Job summary

Madrigal Pharmaceuticals, Inc. seeks an Associate Director of API Quality Assurance (GMP) to lead the quality strategy for API and intermediates across external CMOs/CDMOs. You will ensure ICH Q7 compliance, drive CAPA, and maintain inspection readiness while partnering with MSAT/CMC teams.

The role requires a strong track record in API QA, external manufacturing oversight, and readiness for FDA/EMA inspections, with leadership of QA staff and cross‑functional governance forums.

Qualifications

• BS/MS in a scientific discipline with GMP experience preferred.
• 10–12 years GMP pharma/biotech API quality and CMO oversight experience.
• Proven track record in API batch disposition, deviation/CAPA, and change control governance.
• Experience supporting health authority inspections (FDA/EMA) and external manufacturing networks.

Responsibilities

• Own GMP API QA strategy, governance, and standards across external API manufacturers.
• Lead quality oversight of API and intermediate manufacturing at CMOs/CDMOs for ICH Q7 compliance.
• Oversee API batch record review quality, documentation rigor, and traceability of decision rationale.
• Drive deviation impact assessment, RCA rigor, CAPA linkage, and verification of effectiveness.

Skills

API QA leadership

GMP compliance

ICH Q7 knowledge

External partner oversight

Deviation/CAPA management

Change control governance

Veeva Vault Quality

Education

BS in science

MS/PhD (preferred)

Tools

Veeva Vault Quality

Job description

## Associate Director, API Quality Assurance (GMP)Applylocations: Remote - UStime type: Full timeposted on: Posted 3 Days Agojob requisition id: JR\_000809Madrigal 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.Leads GMP API Quality Assurance to ensure compliant, risk-based oversight of active pharmaceutical ingredient (API) and intermediate manufacturing across external CMOs/CDMOs. Owns API-specific quality strategy, governance cadence, and performance management to enable predictable supply and consistent compliance with ICH Q7 and global health authority expectations.Establishes standards for API batch documentation review, deviation and change control management, and partner performance trending. Partners with MSAT, Supply Chain, Regulatory, and CMOs on tech transfer readiness, control strategy evolution, and lifecycle management of commercial APIs. Maintains inspection readiness through robust documentation control, evidence packages, and decision rationale traceability.**Key Responsibilities*** Own GMP API Quality Assurance strategy, governance cadence, and standards across external API manufacturers* Lead quality oversight of API and intermediate manufacturing at CMOs/CDMOs, ensuring ICH Q7 and global GMP compliance* Set expectations for API batch record review quality, documentation rigor, and decision rationale traceability* Drive deviation impact assessment, RCA rigor, CAPA linkage, and effectiveness verification for API quality events* Oversee change control review and approval for API processes, specifications, methods, and partner-initiated changes* Maintain quality agreements with API CMOs and lead performance governance routines (KPIs, scorecards, QBRs)* Partner with MSAT/CMC on API control strategy evolution, validation readiness, and tech transfer to/from partners* Ensure quality oversight across the API lifecycle, including PPQ, routine manufacturing, and post-approval changes* Lead inspection readiness for API operations, including documentation, evidence packages, and audit response narratives* Support FDA, EMA, and other health authority inspections related to API manufacturing and partner audits* Drive trending and recurrence prevention for API quality events; deliver management review-ready insights* Lead and mentor API QA staff and provide quality input on cross-functional governance forums**Required Qualifications*** BS or MSc in a scientific discipline (Chemistry, Chemical Engineering, Pharmacy, or related)* 10-12 years of GMP pharmaceutical/biotech experience with significant focus on API quality and CMO oversight* Demonstrated leadership in API batch disposition, deviation/CAPA, and change control governance* Strong knowledge of ICH Q7, ICH Q8-Q11, FDA, EMA, and global API regulatory expectations* Proven track record managing external API manufacturers and supporting health authority inspections**Preferred Qualifications*** Advanced degree (MS/PhD) and experience with small molecule API and/or oligonucleotide manufacturing* Experience supporting tech transfers, validation, and post-approval change management at API CMOs* Experience with Veeva Vault Quality (eQMS) and quality metrics/trending for API operations* Experience in pharmaceutical / biotech external manufacturing networks (preferred)**Key Competencies*** API quality governance, ICH Q7 compliance interpretation, and risk-based oversight discipline* External partner oversight, quality agreements, and performance management across API CMOs/CDMOs* Deviation impact assessment, CAPA linkage, and effectiveness verification, recurrence prevention, and trending insights* Change control governance and risk-based impact assessment for API processes, specifications, and methods* Cross-functional leadership, escalation, and executive-ready risk / decision communication* Inspection readiness documentation rigor, audit narrative development, and evidence retrieval readiness* Veeva Vault Quality (eQMS) proficiency to manage API quality events, partner oversight, and inspection-ready evidenceMadrigal’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 $169,000-$198,000 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 [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. 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* *[e-mail]**.*