Quality Recruiting. Established Experts.

Director of Quality

Reference Number: 2815
Location: NC

Our client is a worldwide leader in contract pharmaceutical development and manufacturing.  They have asked us to assist them in their search for a Director of Quality.

Major tasks and responsibilities will include:

  • Develops/improves Quality Systems, programs, and procedures to promote, facilitate, and ensure compliance with domestic and international regulatory and industry standards and implements risk-based methodologies to improve efficiencies.
  • Develops key quality processes, metrics and indicators to measure, trend and improve key quality determinants of all aspects of GxP operations.
  • Effectively communicates progress and issue resolution to appropriate internal/external stakeholders and at Quality Management Review.
  • Establishes and manages the review and audit of internal department processes for compliance with applicable GCP, GMP and/or GLP regulations.
  • Ensures a robust and risk-based audit program is successfully realized throughout our client’s vendor network.
  • Facilitates the appropriate authoring and implementing of QA SOPs in addition to the review of functional SOPs.
  • Promotes a culture of quality and operational excellence.
  • Effectively represents Quality to local and regulatory agencies.
  • Facilitates resolution of problems of diverse scope using a high degree of personal judgment.
  • Assures compliance and consistency to Out of Specification (OOS), Investigations, Deviations and CAPAs throughout vendor network.
  • Ensures the Quality Systems support the strategic plan to advance the company's mission and objectives.
  • Manages the release and disposition of all biologics & gene therapy products.
  • Ensures GxP compliant Quality Management practices and procedures at manufacturing and testing sites.

We seek candidates with the following qualifications:

  • Minimum of 12+ years of experience in a Quality Assurance/Quality Systems and Compliance position in soft gels/solid dose/parenterals/packaging.
  • Degree in scientific discipline required.
  • Must have the experience and ability to provide the organization with the leadership required to develop, implement and maintain quality systems and standards ensuring the Company is in compliance with GxP.
  • Must have extensive product disposition experience.
  • Must have experience with CMOs and commercial supply chains for biopharmaceutical products.
  • Demonstrated knowledge and direct experience with developing and establishing Quality Systems and GxP compliance within a regulated environment.
  • Must have experience establishing validated documentation systems and a strong understanding of 21 CFR Part 11 requirements.
  • Excellent interpersonal skills and ability to effectively interact with and influence different functional groups at all levels of management of the company.
  • Extensive knowledge of the pharmaceutical/biotech industry and FDA, ICH and in-depth knowledge of GxP regulations.
  • Must be well organized and have the ability to communicate system concepts and their applications.
  • Excellent oral and written communication skills for effectively interfacing with internal and external organizations.
  • Strong initiative and ability to assume significant project management skills.
  • Must have excellent attention to detail and time management skills as well as the ability to manage multiple priorities with aggressive timelines and changing priorities.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2815. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.