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Vice President, Head of Quality

  • Job type: Permanent
  • Location: Columbus, Ohio
  • Salary: US$280000 - US$330000 per year
  • Job reference: 288801/005_1555369067
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 15/04/2019

Vice President, Head of Quality

Columbus, Ohio

A large sterile injectable manufacturer is actively seeking a Vice President, Head of Quality to join its team. This role is a apart of the executive leadership, and will be responsible for harmonizing quality systems at all company sites. This company currently produces over 60 million injectables per year resulting in over 1 billion dollars in revenue. If you are looking for an opportunity to accelerate your career with a rapidly expanding company that don't hesitate to apply!

The Vice President, Head of Quality will be responsible for:

  • Assure that products manufactured, packaged, tested and released are in compliance with all applicable standards, laws and regulations and guidelines (including cGMPs), compendia requirements, and company policies.

  • Assure that Clinical Trials sponsored or conducted adhere to Good Clinical Practice (GCP) including but not limited to CFR 21 Part 50 and 54 and ICH E2A and E6.

  • Through reporting departments, ensure that the proper action programs are established and implemented to correct any shortcomings and to meet current and future regulatory related initiatives in the company's quality assurance programs.

  • Develop and implement regulatory strategies and will negotiate such with regulatory agencies to achieve favorable outcomes regarding quality assurance and regulatory compliance matters.

  • Establish policies, procedures and processes to ensure an effective quality systems are maintained.

  • Hire, direct, motivate and develop reporting staff.

  • Prepare and control budgets for reporting departments.

  • Act as Senior Management's advisor on all quality matters for the company.

  • Establish company quality strategy, initiatives and effective policies ensuring alignment with business goals and objectives.

  • Serve as a liaison between company and government regulatory agencies.

The ideal candidate will have:

  • A Bachelor's Degree, preferably in Chemistry or other Life Science; advanced Degree in Science preferred.

  • Minimum 8 years' management experience.

  • Sterile Injectable manufacturing experience.

  • On-site aseptic manufacturing experience.

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