Manager, Quality Assurance
3 days left
- Full Time
The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning.
Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.
The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.
Job Profile Title
Job Description Summary
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. 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.
The Quality Assurance (QA) Manager is a team member of the Quality Assurance (QA) within the Gene Therapy Program (GTP) at the University of Pennsylvania, supporting the development, manufacture, and testing of viral vectors for early phase clinical trials, with an emphasis upon Good Laboratory Practices (GLPs) by assisting QA Management with task assignments. The QA Manager performs all activities of QA Associate performs, including audits of protocols, in-life critical phases, raw data and final reports of basic to medium complexity for both routine and specialty study designs. Audits plans are developed to assure accuracy and compliance with GLP and Standard Operating Procedures (SOP) and maintain written and signed records of auditing activities. The QA Associate, will have primary responsibility for managing and maintaining the SOP document system and assisting with oversight of training files. With input from QA Management, uses discretion and independent judgment in providing recommended corrective actions to management and the study director.
- A Bachelor’s degree in life sciences and 7-10 years of experience in a quality assurance role or an equivalent combination of education and experience is required
- Experience effectively managing a team, including work flow management & performance management
- Experience working in GLP/GMP environment and strong knowledge of GLP/GMP’s required
- Experience in cell and gene therapy is strongly preferred.
- Demonstrated ability to work collaboratively, multi-task, and prioritize in a fast-paced environment a must
- Strong analytical skills and attention to details required
- Must have demonstrated experience meeting critical deadlines.
- Experience with Microsoft word, excel and access required. Proficiency with access databases preferred.
Job Location - City, State
Department / School
Perelman School of Medicine
$59,703.00 - $113,435.00
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