Senior Director Quality Assurance Unit Lead
3 days ago
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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