Senior Director, Quality Management

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.

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

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.

Licenses:

• RAC (Regulatory Affairs Certification)--Preferred
• Certified Quality Auditor (CQA) or Certified Quality Manager (CQM) by ASQ--Preferred
• GMP/GDP/GCP training certifications--Preferred
• Knowledge of electronic Quality Management Systems (eQMS)--Required

The annual salary for this position ranges from $240,000 to $260,000 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.