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Director, Quality Management - Sterile Operations

Amneal India
Brookhaven, USA
Full-time
Director · 12+ years experience
Onsite
Discovered 1 weeks ago

Full Job Posting

Qualifications

  • Education:
  • Bachelors Degree (BA/BS) Pharmaceutical Sciences, Chemistry, Microbiology, Engineering, Life Sciences, or related technical discipline - Required
  • Master Degree (MS/MA) Relevant scientific, engineering, quality, or business discipline - Preferred
  • 12 years or more in Progressive pharmaceutical Quality Assurance / Quality Management experience in an FDA-regulated GMP environment, with increasing leadership responsibility within Sterile Manufacturing area
  • 7 years or more in Direct experience supporting sterile drug-product manufacturing and/or sterile facility start-up, including aseptic processing and sterility assurance.
  • 5 years or more in Quality oversight of capital projects, brownfield or greenfield facility design, construction, commissioning, qualification and validation through operational handover.
  • Technical Quality leadership for one or more of the following: terminal sterilization, BFS, PFS, IV bags, aseptic filling, barrier technology (RABS/isolators), sterilization/depyrogenation, clean utilities and environmental monitoring.
  • Successful support of PPQ/commercial readiness, regulatory inspections and inspection responses for sterile manufacturing operations.
  • 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.

Experience:

  • Specialized Knowledge:
  • The salary range for this position ranges from $190,000 - $200,000 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.

Preferred Qualifications

  • Master Degree (MS/MA) Relevant scientific, engineering, quality, or business discipline - Preferred
  • The salary range for this position ranges from $190,000 - $200,000 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.

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