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Senior Director of Quality Assurance, External Quality

Reference Number: 2844
Location: MA

Our client is a rapidly growing biopharmaceutical company.  They have asked us to assist them in their search for a Senior Director of Quality Assurance, External Quality.

The Senior Director of Quality Assurance, External Quality will ensure that an effective Supply Chain Quality Assurance function is established and managed so that the Quality of the company’s products is maintained, the patient’s interests are protected, and the company’s Quality objectives are met.

Major tasks and responsibilities will include:

  • Provides leadership and management of the Supply Chain QA Department.
  • Responsible for the QA oversight of drug substance and drug product contract manufacturers and contract test labs.  Performs audits.
  • Responsible for commercial/clinical lot release.  Assures that all products are released in compliance with company procedures.
  • Ensures that appropriate Quality policies are applied to the products and to the site’s Manufacturing and Contract Operations in accordance with regulatory requirements.
  • Ensures that policies and procedures needed for the quality management system are established, implemented and maintained and revised as needed as it relates to outsourced manufacturing and testing.
  • Establishes and manages Supplier Quality performance goals and improvement objectives.
  • Promotes a culture of total quality, operational excellence, and continuous improvement.
  • Recruits, motivates, leads, and develops the Quality Assurance team.
  • Ensures Quality operations are managed in a cost effective manner in line with the approved budget.
  • Keeps abreast of industry developments – new technology, forthcoming regulations, competitor activity, etc.
  • Quality planning (anticipation and action plan).
  • Enhances the reputation of the company via site excellence and on-going maintenance of external regulatory body relationships.
  • Assures that contract manufacturer organizations are in compliance with appropriate Quality practices to meet the desired quality attributes of the company and to ensure the facilities/Quality Systems pass regulatory inspections.
  • Provides support for the licensing (CTD/NDA/BLA or IND) approval of new products.

We seek candidates with the following qualifications:

  • BS required, MS/PhD preferred in Biological Sciences, Chemistry or Pharmaceutical Engineering.
  • Good knowledge of GxP regulations is required.
  • 10 years of industry experience in a site producing pharmaceutical products under EU and US standards including 5 years of quality management experience.
  • Direct experience in the approval/licensure and launch of a biological product is preferred

 

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 2844. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.