Director, Quality Management
Amneal
Summary
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.
Job description
Essential Functions
- 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.
Qualifications
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.
Requirements
- Bachelors Degree (BA/BS) in Chemistry, biology, Pharmacy, engineering or other technical fields
- 15 years or more in QA, QC, Compliance in pharmaceutical manufacturing company
- 5 years or more working experience with USFDA
- 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
Benefits
- Health Insurance
- Short-term incentive opportunity
- Long-term incentive award
- Restricted stock units
- 401(k) matching contribution
- Employee well-being programs
Company overview
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is a leading American publicly traded pharmaceutical company headquartered in Bridgewater, New Jersey. Founded in 2002 by brothers Chirag and Chintu Patel, the company has grown to become one of the largest and fastest-growing generic pharmaceutical manufacturers in the United States. Amneal operates as an integrated pharmaceutical company focused on developing, manufacturing, and distributing generic, brand, and biosimilar products. With approximately 8,100 employees globally, the company maintains operations across North America, Asia, and Europe. Amneal's business is organized into three main segments: a robust U.S. generics business with over 250 product families, a growing specialty pharmaceuticals division focused on central nervous system disorders and endocrine conditions, and an expanding biosimilars portfolio. The company has established itself as a leader in complex dosage forms and difficult-to-manufacture products, with manufacturing capabilities spanning oral solids, injectables, ophthalmics, liquids, topicals, transdermals, and respiratory devices. Amneal's mission 'We make healthy possible' reflects its commitment to providing affordable access to essential medicines while maintaining high-quality standards across its global operations.