Description:
The Director, Quality Management - Sterile Manufacturing serves as the senior Quality representative responsible for providing end-to-end Quality leadership for sterile manufacturing expansion, from concept, design, construction, and commissioning through qualification, process validation, regulatory readiness, commercial launch, and routine GMP manufacturing operations.
This role provides independent Quality oversight and decision-making across Terminal Sterilization (TS), Blow-Fill-Seal (BFS), Pre-Filled Syringe (PFS), and IV Bag manufacturing, including both terminally sterilized and aseptically processed operations.
The Director ensures that facilities, utilities, equipment, computerized systems, processes, contamination control strategies, laboratories, documentation, and operating practices are designed, qualified, operated, and maintained in compliance with applicable FDA regulations, EU GMP requirements (including Annex 1), ICH guidance, USP standards, company policies, and the approved regulatory strategy.
The position partners closely with Engineering, Validation, Manufacturing, MS&T, Microbiology, Quality Control, Regulatory Affairs, Supply Chain, EHS, and project leadership to support successful project execution and operational excellence, while maintaining the appropriate level of Quality independence and authority for GMP decision-making, risk assessment and acceptance, release readiness, and quality-related escalation.
Essential Functions:
- Provide independent Quality oversight and approval of the commissioning and qualification lifecycle, including URS, design qualification, FAT/SAT strategy, commissioning turnover, IQ/OQ/PQ, qualification deviations, traceability, and final reports for facilities, utilities, equipment, laboratories, and critical computerized systems.
- Provide Quality oversight for the qualification and validation of critical utilities and systems, including HVAC, WFI, purified water, clean steam, compressed gases, sterilizers/autoclaves, depyrogenation systems, filling equipment, BFS systems, PFS lines, IV Bag lines, CIP/SIP systems, isolators/RABS, environmental monitoring systems, and cold chain/storage systems, as applicable.
- Lead Quality governance for aseptic process simulations (media fills), sterilization cycle development and validation, depyrogenation validation, container closure integrity testing, cleaning validation, hold-time studies, shipping qualification, filter validation, and other critical validation programs required for commercial readiness.
- Ensure the Pharmaceutical Quality System is operational before GMP start-up, including procedures, document control, training, deviation/OOS/OOT management, CAPA, change control, risk management, supplier quality, complaint management, APR/PQR, batch record control, audit trail review, data governance, and management review processes.
- Approve GMP readiness of Manufacturing, QC, and Microbiology operations, including laboratories, methods, specifications, sampling plans, environmental and utility monitoring programs, sterility assurance controls, microbiological identification strategies, environmental monitoring qualification, gowning qualification, and personnel aseptic qualification.
- Provide Quality oversight for engineering, process development, exhibit and registration batches, PPQ, and commercial manufacturing batches. Ensure deviations are scientifically investigated, critical process parameters and quality attributes are controlled, batch records are complete, and disposition decisions are supported by documented evidence and approved procedures.
- Lead inspection and regulatory readiness activities for the new sterile manufacturing operation. Support regulatory submissions, pre-approval inspections, and health authority inspections, ensuring commitments, responses, CAPAs, and inspection observations are addressed with technically sound and sustainable corrective actions.
- Build and develop the Sterile Quality organization, including role definition, staffing plans, technical competency requirements, qualification curricula, succession planning, and routine performance governance. Establish a strong Quality culture that emphasizes right-first-time execution, timely escalation, and science- and risk-based decision-making.
- Following commercial launch, maintain Quality oversight of routine sterile manufacturing operations, including continued process verification, sterility assurance, environmental and utility trend monitoring, deviation management, CAPA effectiveness, change control, periodic reviews, Product Quality Reviews (PQRs), inspection readiness, and continuous improvement to sustain a state of control.
Additional Responsibilities:
- Manage daily performance of staff.
- Ensures projects, goals and deadlines are being met.
- Adhere to all budget requirements. Maintain high-level of confidentiality, in regard to Company and employee information.
- Additional responsibilities as assigned.
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.
Education:
- Bachelors Degree (BA/BS) Pharmaceutical Sciences, Chemistry, Microbiology, Engineering, Life Sciences, or related technical discipline - Required
- Master Degree (MS/MA) Relevant scientific, engineering, quality, or business discipline - Preferred
Experience:
- 12 years or more in Progressive pharmaceutical Quality Assurance / Quality Management experience in an FDA-regulated GMP environment, with increasing leadership responsibility within Sterile Manufacturing area
- 7 years or more in Direct experience supporting sterile drug-product manufacturing and/or sterile facility start-up, including aseptic processing and sterility assurance.
- 5 years or more in Quality oversight of capital projects, brownfield or greenfield facility design, construction, commissioning, qualification and validation through operational handover.
Specialized Knowledge:
- Technical Quality leadership for one or more of the following: terminal sterilization, BFS, PFS, IV bags, aseptic filling, barrier technology (RABS/isolators), sterilization/depyrogenation, clean utilities and environmental monitoring.
- Successful support of PPQ/commercial readiness, regulatory inspections and inspection responses for sterile manufacturing operations.
The salary range for this position ranges from $190,000 - $200,000 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.