Senior Director Quality Assurance Unit Lead

3 days ago


Philadelphia, Pennsylvania, United States InsideHigherEd Full time
Job Title: Senior Director Quality Assurance Unit Lead

Job Summary: We are seeking a highly experienced Senior Director Quality Assurance Unit Lead to lead our GXP Quality Assurance Unit (QAU), including GLP/GMP's within GTP, supporting the development, manufacture, and testing of viral vectors for clinical trials.

Key Responsibilities:

  • Lead a QAU that provides support for a GLP non-human primate (NHP) facility and GLP studies performed in a partial-GLP rodent facility, in addition to overall QAU support for GLP studies performed in the GTP labs.
  • Ensure GLP and GMP compliance across identified groups within the GTP.
  • Manage and coordinate the QAU, and ensure that all cell and gene therapy products comply with the requirements of FDA and other health authority or regulatory/accreditation bodies.
  • Interact with senior management staff and directors of other functional groups within GTP.

Requirements:

  • Minimum of a Master's degree in life sciences.
  • 7 to 10 years of pharmaceutical/biopharmaceutical QAU experience with documented training in GLP/GMP or an equivalent combination of education and work-related experience.
  • ASQ certification.
  • At least 2 years of senior leadership experience in vaccines/biotechnology industry preferred.

What We Offer:

  • Competitive salary and benefits package.
  • Opportunity to work with a leading organization in the gene therapy space.
  • Collaborative and dynamic work environment.

How to Apply: If you are a motivated and experienced professional looking for a new challenge, please submit your application, including your resume and a cover letter, to [insert contact information].



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