SR DIRECTOR QUALITY ASSURANCE UNIT at University of Pennsylvania in Philadelphia, Pennsylvania

Job Description:

Duties: The Gene Therapy Program (GTP) is entering a new era of unprecedented opportunity with the great potential to reshape the face of medicine as we know it. Our discoveries have set the stage for successful treatments and possibly even cures for devastating genetic diseases.
The laboratory of Dr. James Wilson, at GTP of the University of Pennsylvania, has been a leader in the development of innovative vector technology for close to three decades. We have emerged as the 'go-to' organization for public and private partners, who want to participate in the gene therapy space. 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.
We are currently searching for a Senior Director, Quality Assurance(SDQA) to lead a GXP Quality Assurance Unit (QAU), including GLP/GMP's within GTP, supporting the development, manufacture, and testing of viral vectors for clinical trials.
As the SDQA, you will be responsible for a QAU that will provide 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 (eg, analyses for IND-enabling studies). The QAU will support the comparable GMP production activities related to GLP toxicology lot production and GMP-related technical transfer activities as it relates to clinical batch release testing conducted at GTP to support the clinical CMO. The QAU will also provide Quality Assurance support to the research-based portion of the GTP, in terms of SOP management, training, document management and archiving, and audit support. You will interact with the senior management staff and directors of the other functional groups within GTP and will be responsible for ensuring GLP and GMP compliance across identified groups within the GTP. You will ensure Quality Assurance oversight, 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.

Qualifications: The minimum of a Master's degree in life sciences and 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 required, as well as ASQ certification. At least 2 years of senior leadership experience in vaccines/biotechnology industry preferred. Knowledge of cell-based production and working knowledge of the guidelines for GLP / GMP required. Familiarity with QA/QC and manufacture of viral vectors preferred. Demonstrated ability to multi-task and prioritize in a fast-paced environment.

Reference Number: 40-30190

Salary Grade: 031

Employment Type: Exempt

Org: DM-Gene Therapy Program

Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

Job Family: B-Executive/Managerial Administration