Associate Director, QA Operations

3 weeks ago

King of Prussia, United States Gene Therapy Program | University of Pennsylvania Full time

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. GTP is a complex R&D organization consisting of research laboratories supported by multiple core functions which provide internal capacity to perform gene transfer studies from basic research through Phase 1 proof-of-concept human trials.



The information below covers the role requirements, expected candidate experience, and accompanying qualifications.

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. 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.

Continuation of all GTP positions is contingent upon funding.

Summary

The Associate Director will provide management of the Quality Operations in support of internal quality initiatives as well as oversight of GMP activities at CDMO's. 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)

The Associate Director of Quality Assurance Operations will assist and support Gene Therapy Program (GTP) business initiatives by ensuring timely completion of assignments through collaboration with GTP internal departments. Primary responsibilities include provision of Quality oversight of internal validation activities (equipment/instruments) as well as Quality oversight of GMP Manufacturing Operations in accordance with applicable regulations and target timelines. This individual will need to have a strong understanding/knowledge of cGMP's and technical experience with qualification/validation (IQ/OQ/PQ) of equipment/instruments. (Analytical testing experience also preferred.)

Qualifications

  • Bachelor's Degree in relevant discipline and 7-10 years of experience or equivalent combination of education and experience is required.
  • Previous supervisory experience; working knowledge of SMART goals.
  • Working knowledge/experience/oversight of Quality Management Systems (i.e. Quality Manual, Document Control, Document Archival).
  • Knowledge of GxP regulations (GMP/GLP/FDA Guidelines/21 CFR Parts 210 & 211/ICH).
  • Prior experience/knowledge in DMAIC and Lean Six Sigma (preferred).
  • Prior experience with generation of metrics, monitoring key quality systems/KPIs, data analysis, including development and provision of reports for Quality Management review.
  • Prior experience with risk management and change management.
  • Knowledge of Veeva QualityDocs (preferred).
  • Working knowledge/experience with Excel and Vizio (preferred).
  • Strong organizational and interpersonal skills.
  • Ability to interact, effectively communicate and collaborate with individuals from all levels of the organization.
  • Ability to manage multiple priorities in accordance with aggressive timelines.

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