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SR DIRECTOR QUALITY ASSURANCE UNIT

Employer
University of Pennsylvania
Location
Philadelphia, PA

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Executive Administration Jobs
Other Executive Administration
Employment Type
Full Time
Institution Type
Four-Year Institution

Job Details

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

Organization

Welcome to the University of Pennsylvania! Penn is the largest private employer in Philadelphia and is a world-renowned leader in education, research, and innovation.  

Across our 12 highly-regarded schools, more than 25,000 students, and more than 4,000 faculty members, we become one university: a wide-ranging, ever-changing community that draws its strength from a multitude of races, ethnicities, genders, sexual orientations, historical traditions, ages, religions, disabilities, veteran status, interests, perspectives, and socioeconomic backgrounds. 

Penn carries on the principles and spirit of its founder, Benjamin Franklin: entrepreneurship, innovation, invention, outreach, and a pragmatic love of knowledge. Franklin's practical outlook has remained a driving force in the university's development. To learn more, visit About Penn

Vision

 

As engines of knowledge and new ideas, universities have the unique potential to define the future rather than be defined by it; to pioneer change rather than merely manage it. To do so requires a plan both visionary and pragmatic. The Penn Compact 2022 motivates community members to innovate, be radically inclusive, and positively impact their local, national, and global communities. 

 

Penn’s fundamental priorities — increasing access, integrating knowledge and engaging locally, nationally and globally — are supported by the three core values that make us uniquely Penn: inclusion, innovation, and impact. 

 

Learn about the signature initiatives of the Penn Compact 2022:  

 

Diversity 

 

Understanding and appreciating diversity is one of Penn's most important priorities and is fundamental to success in today's world. 

 

Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class. 

 

To learn more about Diversity and Inclusion at Penn visit: 

 

Benefits 

 

Penn offers a wide range of benefits and perks - from Penn's retirement Matching Plan to bike repair stations to access to the full LinkedIn Learning library to adoption assistance to workshops at the letterpress and book arts studio and much more! 

 

Campus and Beyond

 

We invite you to explore our campus and its stately buildings and state-of-the-art facilities. 

 

Try our self-guided tour! Come and visit

 

Learn about sustainability at Penn

 

News 

 

Stay up-to-date with Penn's response to COVID-19: Coronavirus Information & Resources

 

Penn supports news publications that tell the ongoing story of the University community, communications services for external media, telephone and video services, and other media resources: Campus Media 

 

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Company info
Telephone
(215) 898-7372
Location
3451 Walnut Street
Philadelphia
PA
19104
US

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