DESCRIPTION:

The Sr. 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.

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

SKILLS:

• Excellent written and oral communication skills, demonstrated abilities in problem-solving, decision-making, planning, coaching and leadership. - Proficient

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.

• 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.