New · posted Oct 15
Amneal Pharmaceuticals · Pharmaceuticals
Director, Quality Management - Sterile Operations
- Brookhaven, NY
- On-site
- Full-time
- Director
Open until filled
The role
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.
What you need
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.
Skills named in this posting
What you'll do
- 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.
- 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.
Pay and benefits
$190,000 – $200,000 a year
Employer providedShort-term incentive (bonus or performance-based award)
Long-term incentive (restricted stock units)
Health and insurance benefits
401(k) matching contribution
Employee well-being programs
Where you'll work
Brookhaven, NYOn-siteOpen in Maps (opens in a new tab)
More jobs in Brookhaven, NYJob intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 7% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Director roles in the US102 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $190,000 | — | $200,000 |
| All US (middle half) | $186,500 | $209,250 | $231,375 |
This role: Amneal Pharmaceuticals's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Amneal's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 25 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance9
- Validation and qualification8
- Collaboration and leadership8
- Lab testing and methods6
- Documentation and SOPs4
- Investigations and CAPA4
- Quality systems and risk3
- Data and digital systems3
- Regulatory submissions2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and Practices
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- European CommissionEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules and annexes
- USPUSP compendial chapters(official source, opens in a new tab)Bioburden (USP <61>), endotoxin (USP <85>), TOC (USP <643>) and water testing
Company hiring pulse
Amneal on Regulatory Jobs
- 14
- Open roles
- 10
- Distinct roles
- 2
- Locations
By discipline
- Quality14 100%
By level
- Senior & Principal7 50%
- Associate & Specialist4 29%
- Manager2 14%
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Director, Quality Management - Sterile Operations at Amneal
Open until filled. $190K–$200K a year, employer provided.