Director, External Quality Management
About The Position
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 externally manufactured or tested products meet Amneal quality standards, approved regulatory filings, and applicable cGMP requirements, while retaining the Quality Unit's accountability for outsourced operations. Reporting to the Vice President, Corporate Quality, the Director leads External Quality Managers and QA Leads and works closely with Supply Chain, Procurement, Research & Development, and Regulatory Affairs. The Director establishes risk-based partner oversight; leads the team and develops its capabilities, procedures, tools, and standards; oversees partner qualification, quality agreements, audits, and supplier approval; and governs batch disposition and product quality activities. The role also oversees partner deviations, investigations, CAPAs, change controls, regulatory alignment, and quality assessments for field alerts, recalls, and market actions. It provides quality oversight for technology transfers, site transfers, process validation, and new product launches at external sites.
Requirements
- Bachelor's degree in Chemistry, Biology, Pharmacy, Engineering, or another technical field.
- 15 or more years in QA, QC, or Compliance in a pharmaceutical manufacturing company.
- 5 or more years in External / CMO quality oversight.
- Demonstrated quality oversight of a large, multi-site CMO network across dosage forms, including 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.
Nice To Haves
- Master's degree in Chemistry, Biology, Pharmacy, Engineering, or another technical field.
Responsibilities
- 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 determines audit frequency, on-site presence, and review depth.
- Serve as the senior Quality decision-maker for external manufacturing issues, product impact assessments, and escalations; represent External Quality in management review and Quality Council forums.
- Lead, coach, and develop External Quality Managers and QA Leads; assign partner portfolios and balance workload across 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, fostering quality ownership, independent challenge, transparency, and continuous improvement.
- 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 and ensure audit observations are tracked to effective closure.
- Lead quality disqualification and exit decisions for persistently non-compliant partners.
- 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.
- Ensure partner-site deviations, OOS/OOT results, and complaints are investigated thoroughly and in a timely manner.
- Challenge root cause analyses for scientific rigor and identification of systemic contributors; approve CAPAs and verify their 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.
- 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 and 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.
Benefits
- Short-term incentive opportunity, such as a bonus or performance-based award.
- Long-term incentive award, such as restricted stock units, within the first 12 months.
- Comprehensive, flexible, and competitive benefits program for eligible positions.
- Health and insurance benefits.
- 401(k) matching contribution.
- Employee well-being programs.
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What This Job Offers
Job Type
Full-time
Career Level
Director
