New · posted Nov 10
Amneal Pharmaceuticals · Pharmaceuticals
Director, Quality Management
- Piscataway, NJ
- On-site
- Full-time
- Director
The role
The Director, Quality Management is responsible for standardization and proactive compliance of Amneal's Quality Management System (QMS) with the worldwide drug, biologics and combination products regulations and standards. This role is responsible for compliance monitoring, compliance risk identification, quality plan for new requirements, site inspection readiness, and regulatory authority (FDA, …) inspection support.
What you need
Education
- Bachelors Degree (BA/BS) Chemistry, biology, Pharmacy, engineering or other technical fields - Required
- Master 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 Working experience with USFDA
Specialized Knowledge
- Extensive experience in regulatory quality systems and compliance strategy.
- Leadership of global compliance programs and teams.
- Strong background in interacting with regulatory agencies.
- Proficient level knowledge of international regulation and standards (e.g., ICH, FDA, EMA).
- Strong attention to detail and organizational skills.
The salary range for this position ranges from $200,000 - $245,000 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.
What you'll do
- Lead network wide regulatory commitments monitoring and implementation of associated corrective and preventive actions (CAPAs). Identify compliance risks and implement corrective and preventive actions.
- Support external audits and inspections from regulatory agencies. Co-ordinate with site leaders in addressing inspection findings including draft response.
- Implement quality system compliance intelligence enabling proactive monitoring of changes in the worldwide drug, biologics, device regulations and guidance.
- Review of changes in regulations, gap assessment, development of action plan, and implementation. Interpret and communicate regulatory requirements to internal stakeholders.
- Participate in internal audits to ensure compliance with GMP, GCP, GLP, and other applicable standards. Identify potential non-compliances and suggest mitigation.
- Analyze current industry compliance trends and Amneal sites’ compliance ratings to establish compliance risks.
This position requires 30-40% travel both domestic and international.
Pay and benefits
$200,000 – $245,000 a year
Employer providedShort-term incentive (bonus)
Long-term incentive (restricted stock units)
Health and insurance benefits
401(k) matching contribution
Employee well-being programs
Where you'll work
Piscataway, NJOn-siteOpen in Maps (opens in a new tab)
More jobs in Piscataway, NJJob intelligence
The context around this role
Live data · November 10, 2026
Salary intelligence
How the pay compares
This role's midpoint is 4% above the US median for Quality Systems & Document Control roles at this level.
This roleEmployer provided
Director roles in the US11 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $200,000 | — | $245,000 |
| All US (middle half) | $189,500 | $213,500 | $231,000 |
This role: Amneal Pharmaceuticals's own published range. Comparisons: the base pay employers published on open Quality Systems & Document Control roles at the same level on Regulatory Jobs, November 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Systems & Document Control
The general path across 91 open Quality Systems & Document Control roles on Regulatory Jobs, with the titles they carry most. Not Amneal's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 18 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance11
- Quality systems and risk3
- Collaboration and leadership3
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Systems & Document Control work in pharmaceuticals, led by the four this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDA21 CFR Part 4(official source, opens in a new tab)Current good manufacturing practice for combination productsNamed in the posting
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studiesNamed in the posting
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- HHS-OIGHHS-OIG General Compliance Program Guidance(official source, opens in a new tab)The federal government's guide to healthcare compliance programs and the anti-kickback statute
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Amneal on Regulatory Jobs
- 21
- Open roles
- 21
- Distinct roles
- 3
- Locations
By discipline
- Quality21 95%
- Clinical1 5%
By level
- Associate & Specialist9 41%
- Senior & Principal7 32%
- Director4 18%
More roles at Amneal
- View role
Associate Scientist, Quality Control
Piscataway, NJAssociate & SpecialistPharmaceuticals$65K–$80K
- View role
Director, External Quality Management
Piscataway, NJDirectorPharmaceuticals$205K–$236K
- View role
Director, Pharmacovigilance & Drug Safety
Piscataway, NJDirectorPharmaceuticals$200K–$250K
- View role
Quality Assurance Inspector II - 2nd Shift
Piscataway, NJAssociate & SpecialistPharmaceuticals$44K–$56K
Similar Quality Systems & Document Control roles elsewhere
- View role
Director– Quality Management Systems (QMS) & Digital Quality Governance
MerckWilmington, DE +2 more · HybridDirectorPharmaceuticals$173K–$273K
- View role
Associate Director, Quality Management Systems
Kiniksa Pharmaceuticals InternationalLexington, MADirectorPharmaceuticals$186K
- View role
Director, Quality Systems
CytokineticsSouth San Francisco, CA · HybridDirectorPharmaceuticals$225K–$263K
Director, Quality Management at Amneal
Open until filled. $200K–$245K a year, employer provided.