The Clinical Cell and Vaccine Production Facility (CVPF) is the cell manufacturing facility that produces all of the cell and gene therapy products to support the Center for Cellular Immunotherapy (CCI) at the University of Pennsylvania. Under the leadership of Dr. Carl June, world-renowned researcher and pioneer of CAR-T cell therapies, the CCI has become a world leader in clinical manufacture for numerous FDA approved clinical trials and currently recognized as the undisputed leader against other universities and research centers with over 54 CAR T-cell related inventions filed in 428 patents. Our work has already led to groundbreaking FDA-approved personalized cellular therapies, such as the one granted to Novartis last year for the chimeric antigen receptor (CAR) T-cell therapy Kymriah® (tisagenlecleucel, formerly CTL019). We take pride in the work we do and we put our patients first. Hear the story of our first pediatric patient Emily Whitehead right here! https://vimeo.com/54668275 With over 15 open clinical trials, and many more on the pipeline, we are looking for passionate and energetic people to join our amazing group – Join the revolution by joining the CVPF https://youtu.be/KWWuZ8Yt9xA .
Find out about our benefits at: https://www.hr.upenn.edu/PennHR/benefits-pay
The Quality Assurance Leads are critical in supporting the CVPF Quality Management System and the Quality Plan. The QA Lead is responsible of providing cGMP expertise and oversight for quality and compliance support, covering all of the CVPF Functional Areas (Facilities, QC, Operations, Manufacture and Document Control) with the main end goal of ensuring that all final clinical products released by CVPF are compliant.
Specific Responsibilities are listed below:
a) Assist in coordinating and overseeing operational compliance monitoring activities, including providing subject matter expertise to address/resolve quality and compliance related questions. b) Conduct internal inspections (or gap assessments) of processes pertaining to the Functional Area assigned to ensure these are compliant and efficient. Streamlining and process optimization is critical within CVPF. c) Lead Continuous Improvement projects resulting from these aforementioned ongoing gap assessments, or if directly assigned by the QA Director. Project Management skills are required. d) Assist assigned Functional Area in completing investigations, deviations, Out-of-specification reports, etc. Assist in developing robust CAPAs to minimize re-ocurrence of non-conformances and to prevent potential systemic compliance issues. e) Quality Representative in Functional Area Team Meetings, serving as the go-to person answering quality related questions. f) Author, review and/or approve related documents and records, such as for example, SOPs, Work Instructions, and any other documents associated to the assigned Functional area (for example, IQ/OQ/PQ protocols for the Facilities Lead, Analytical Test Methods and Specs for the QC Lab Lead, Work Instructions and Guidelines for Manufacture or QA, etc) g) Review and approve Validation Plans and Scientific Investigation Reports (SIRs), as applicable. h) Create and deliver training modules of quality topics as they pertain to the assigned Functional Area. Facilitate training related activities from a quality standpoint. The QA Leads are to be considered highly knowledgeable in the function they support. i) Assist in activities to support operational areas, such as inspecting and releasing raw materials, Environmental Monitoring, Training, etc, as applicable. j) Serve as the QA Rep or Process Owner, as applicable, for processes assigned by the QA Director (for example, the Materials Management Program, the Training Program, the Document Management program, Environmental Monitoring Plan, and others).
Internal Number: 45032
About University of Pennsylvania
Penn has a long and proud tradition of intellectual rigor and pursuit of innovative knowledge, begun by Benjamin Franklin in 1740. That tradition lives today through the creativity, entrepreneurship, and engagement of our faculty, students, and staff. Academic life at Penn is unparalleled, with an undergraduate student body of 10,000 from every U.S. state and around the world. The entering class of 2015 is the most talented and diverse in Penn's history. Consistently ranked among the top 10 universities in the country, Penn welcomes an additional 10,000 students to our top-ranked graduate and professional schools.