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Associate Director, QA Operations
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- The laboratory of Dr. Jim Wilson, at GTP of the University of Pennsylvania has been a leader in the development of innovative vector technology for close to three decades.
- Currently we are positioned to lead another round of vector innovation and establish pre-clinical and clinical proof-of-concept in therapeutic applications of in-vivo genome editing.
- In this function, the Associate Director will review technical documents, review/approve procedures, evaluate and communicate opportunities for continuous improvements, as well as ensure compliance with internal procedures, current Good Manufacturing Practice (cGMP), and regulatory requirements.
- The primary focus will be support of Quality Systems (Tech Ops and Validation) and compiling/reporting metrics to Senior Management.
- Responsibilities will include providing quality input/oversight of qualification/validation activities for equipment (installation of new equipment, calibration, and maintenance), supporting/maintaining quality systems, providing oversight of GMP activities at CDMO's, and and review of technical documents (which may include review of analytical data)
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