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Global Head, Quality Standards, Policy & External Relations

Reference Number: 2811
Location: NJ

Our client is a major global healthcare company.  They have asked us to assist them in their search for a Global Head, Quality Standards, Policy & External Relations.

Major tasks and responsibilities will include:

  • Leads the development of the Quality Management Systems for the Cell and Gene Therapy Unit.
  • Ensures that the systems including policies, standards, processes and governance developed are “fit for purpose”.
  • Provides a robust framework from the development to future commercialization of safe and effective products which comply with Company GMP/GDP Quality Standards, emerging regulatory standards, and global GMP/GDP guidelines.
  • Principle participant in the proactive engagement of Health Authorities with respect to emerging regulations, and in shaping opinion with respect to Company development programs in the Cell and Gene Therapy area.
  • Co-chairs the Regulatory/QA Policy Committee.
  • Leads the implementation of the Company Quality Manual and works with the Pharma Quality Systems and Standards organization to define and implement the basic requirements for Cell and Gene Therapies.

We seek candidates with the following qualifications:

  • Degree in Pharmacy, Chemistry, Engineering or equivalent Discipline.
  • Minimum 15-18 years of experience in Pharmaceutical, Chemical or Biological Operations.
  • Broad range of experience in QA/QC line functions and/or manufacturing departments.
  • Extensive experience in global and local QA business processes, standards, regulatory requirements, project management, IT systems and other quality related activities.
  • Demonstrated leadership skills through project teams and/or departments.
  • Extensive experience with international Health authority interactions (FDA, EMA, PMDA).
  • Active member of one or more Pharmaceutical Industry Associations preferred.
  • Fluent in English.
  • Ideally fluent in a second language (German, French, Spanish).


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 2811. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.