Description:
The Director, Quality – External Manufacturing leads the External Quality team responsible for quality oversight of Amneal's network of 50+ external manufacturers, including contract manufacturing organizations (CMOs), contract packagers, contract testing laboratories, and API/critical material suppliers across oral solid dose, injectables, and complex products. The role ensures that products manufactured or tested externally meet Amneal's quality standards, approved regulatory filings, and applicable cGMP requirements, and that Amneal's Quality Unit retains full accountability for outsourced operations. Reporting to the Vice President, Corporate Quality, the Director leads a team of External Quality Managers and QA Leads, each accountable for a defined set of partners / activities, and works closely with Supply Chain, Procurement, Research & Development, and Regulatory Affairs.
Essential Functions:
- External Quality Leadership & Network Oversight - Lead quality oversight of 50+ external manufacturers, contract laboratories, and business partners. Establish a risk-based oversight model that tiers partners by product criticality, dosage form, regulatory history, and performance, and sets audit frequency, on-site presence, and review depth accordingly. Serve as the senior Quality decisionmaker for external manufacturing issues, product impact assessments, and escalations. Represent External Quality in management review and Quality Council forums.
- People Leadership - Lead, coach, and develop a team of External Quality Managers and QA Leads; assign partner portfolios and balance workload across 50+ sites. Build team capability in auditing, investigation review, risk assessment, and regulatory requirements. Develop and maintain SOPs, tools, and standard work for external quality oversight. Foster a culture of quality ownership, independent challenge, transparency, and continuous improvement.
- Quality Agreements & Partner Qualification – Own the authoring, negotiation, approval, and periodic review of Quality Agreements. Lead quality due diligence, qualification, and approval of new partners; maintain the Approved Supplier List. Define and execute the CMO and contract laboratory audit program; ensure audit observations are tracked to effective closure. Lead quality disqualification and exit decisions for persistently non-compliant partners.
- Batch Disposition & Product Quality - Ensure timely, compliant review and disposition of externally manufactured batches against approved specifications and registered processes. Oversee review of executed batch records, CoAs, and release testing performed at contract laboratories. Ensure Annual Product Reviews incorporate complete and accurate CMO data and drive actions from trends. Oversee stability program commitments, OOS/OOT trending, and product quality complaints for externally manufactured products.
- Deviations, Investigations & CAPA - Ensure deviations, OOS/OOT results, and complaints at partner sites are investigated thoroughly and in a timely manner. Challenge root cause analyses for scientific rigor and identification of systemic contributors. Approve CAPAs and verify effectiveness; identify recurring issues across partners and drive network-wide preventive actions. Lead quality assessments for field alerts, recalls, and market actions involving external products.
- Change Control & Regulatory Alignment - Govern partner-initiated and Amneal-initiated changes through change control, including product impact and regulatory reportability assessments. Partner with Regulatory Affairs to ensure changes are filed appropriately (CBE-0, CBE-30, PAS, annual report) and that partner operations remain aligned with approved ANDAs/NDAs. Provide quality oversight of technology transfers, site transfers, process validation, and new product launches at external sites.
Qualifications
Education:
- Bachelor's Degree (BA/BS) Chemistry, biology, Pharmacy, engineering or other technical fields - Required
- Master's degree (MS/MA) Chemistry, biology, Pharmacy, engineering or other technical fields - Preferred
Experience:
- 15 years or more in QA, QC, Compliance in pharmaceutical manufacturing company
- 5 years or more in External / CMO quality oversight
Specialized Knowledge:
- Demonstrated quality oversight of a large, multi-site CMO network across dosage forms (oral solids, sterile injectables, and/or complex generics).
- Expert knowledge of 21 CFR Parts 210/211, 21 CFR Part 11, EU GMP, ICH Q7/Q9/Q10, and FDA expectations for Quality Agreements and outsourced manufacturing.
- Experience hosting or supporting FDA inspections and leading 483 / Warning Letter remediation.
- Strong background in investigations, root cause analysis, CAPA, and change control.
The salary range for this position ranges from $205,000 - $236,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months. Amneal ranges reflect the Company’s good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.
At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.
Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at accommodations@amneal.com. Requests will be handled confidentially and in accordance with applicable laws.
