Director, Quality Management
Piscataway, NJJobSeen 2 days agoSeen in employer's feed 2 days ago
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At a glance
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Job overview
The Director, Quality Management leads standardization and proactive compliance of Amneal’s Quality Management System with worldwide regulations and standards for drugs, biologics, and combination products. The role monitors compliance, identifies risks, plans for new requirements, and supports site inspection readiness and regulatory authority inspections. It also analyzes industry compliance trends and site ratings. The position requires 30–40% domestic and international travel.
Skills & qualifications
Skills
Qualifications
Full job description
Description:
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.
Essential Functions:
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Lead network wide regulatory commitments monitoring and implementation of associated corrective and preventive actions (CAPAs). Identify compliance risks and implement corrective and preventive actions.
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Support external audits and inspections from regulatory agencies. Co-ordinate with site leaders in addressing inspection findings including draft response.
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Implement quality system compliance intelligence enabling proactive monitoring of changes in the worldwide drug, biologics, device regulations and guidance.
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Review of changes in regulations, gap assessment, development of action plan, and implementation. Interpret and communicate regulatory requirements to internal stakeholders.
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Participate in internal audits to ensure compliance with GMP, GCP, GLP, and other applicable standards. Identify potential non-compliances and suggest mitigation.
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Analyze current industry compliance trends and Amneal sites’ compliance ratings to establish compliance risks.
This position requires 30-40% travel both domestic and international.
How this job compares
Set against the 605 open Quality Management jobs on Olive Jobs, counted November 12, 2026.
- Pay
- This postingNot listed
- US median$120–178K/yr332 salary ranges
- US median$32–50/hr29 hourly ranges
- Openings
- Olive Jobs lists 23 open Quality Management jobs in New Jersey and 605 across the US. 4% of them nationwide are listed as remote or flexible.
- Hiring the most in New Jersey
- BD (Becton, Dickinson and Company)3 open
- Amneal Pharmaceuticals (this employer)2 open
- J&J Family of Companies2 open
- Experience
- Quality Management postings that state a minimum ask for 7 years of experience at the median; the middle half ask for 5 to 10 years (506 postings).
- Education
- 253 of the 605 open Quality Management jobs (42%) ask for a bachelor's degree or higher.
Counted across the open, public US postings on Olive Jobs on November 12, 2026. Pay medians are the middle values of the low ends and of the high ends of postings that list both ends of a range in the same cadence (a yearly salary or an hourly rate); a range's midpoint is halfway between its ends. Pay and experience figures resting on fewer than 20 postings are left out.
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