Director, Quality Management
About The Position
The Director, Quality Management is responsible for standardizing and proactively ensuring Amneal’s Quality Management System (QMS) complies with worldwide regulations and standards for drugs, biologics, and combination products. The role oversees compliance monitoring and risk identification, develops quality plans for new requirements, supports site inspection readiness, and provides support during regulatory authority inspections. The Director leads network-wide monitoring and implementation of regulatory commitments and related corrective and preventive actions (CAPAs). The position also supports external audits and regulatory inspections, coordinates with site leaders on inspection findings and draft responses, monitors global regulatory changes, assesses gaps, develops and implements action plans, and communicates regulatory requirements to internal stakeholders. The role participates in internal audits and analyzes industry compliance trends and site compliance ratings to identify risks.
Requirements
- Bachelor’s degree in chemistry, biology, pharmacy, engineering, or another technical field.
- At least 15 years of experience in QA, QC, or compliance at a pharmaceutical manufacturing company.
- At least 5 years of work experience with the USFDA.
- Extensive experience in regulatory quality systems and compliance strategy.
- Experience leading global compliance programs and teams.
- Strong background interacting with regulatory agencies.
- Proficient knowledge of international regulations and standards, such as ICH, FDA, and EMA.
- Strong attention to detail and organizational skills.
Nice To Haves
- Master’s degree in chemistry, biology, pharmacy, engineering, or another technical field.
Responsibilities
- Lead network-wide monitoring and implementation of regulatory commitments and associated corrective and preventive actions (CAPAs).
- Identify compliance risks and implement corrective and preventive actions.
- Support external audits and regulatory agency inspections.
- Coordinate with site leaders to address inspection findings, including preparing draft responses.
- Implement quality-system compliance intelligence to proactively monitor changes in worldwide drug, biologics, and device regulations and guidance.
- Review regulatory changes, conduct gap assessments, develop action plans, and support implementation.
- Interpret and communicate regulatory requirements to internal stakeholders.
- Participate in internal audits to assess compliance with GMP, GCP, GLP, and other applicable standards.
- Identify potential non-compliances and recommend mitigation.
- Analyze industry compliance trends and Amneal sites’ compliance ratings to establish compliance risks.
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.
- 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
