Director, External Quality Management
Amneal
Summary
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.
Job description
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.
Requirements
- Bachelor's Degree (BA/BS) in Chemistry, biology, Pharmacy, engineering or other technical fields
- Master's degree (MS/MA) in Chemistry, biology, Pharmacy, engineering or other technical fields preferred
- 15 years or more in QA, QC, Compliance in pharmaceutical manufacturing company
- 5 years or more in External / CMO quality oversight
- 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
Benefits
- Health insurance
- Short-term incentive opportunity
- Long-term incentive award
- Restricted stock units
- 401(k) matching contribution
- Employee well-being programs
Company overview
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is a leading American publicly traded pharmaceutical company headquartered in Bridgewater, New Jersey. Founded in 2002 by brothers Chirag and Chintu Patel, the company has grown to become one of the largest and fastest-growing generic pharmaceutical manufacturers in the United States. Amneal operates as an integrated pharmaceutical company focused on developing, manufacturing, and distributing generic, brand, and biosimilar products. With approximately 8,100 employees globally, the company maintains operations across North America, Asia, and Europe. Amneal's business is organized into three main segments: a robust U.S. generics business with over 250 product families, a growing specialty pharmaceuticals division focused on central nervous system disorders and endocrine conditions, and an expanding biosimilars portfolio. The company has established itself as a leader in complex dosage forms and difficult-to-manufacture products, with manufacturing capabilities spanning oral solids, injectables, ophthalmics, liquids, topicals, transdermals, and respiratory devices. Amneal's mission 'We make healthy possible' reflects its commitment to providing affordable access to essential medicines while maintaining high-quality standards across its global operations.