Executive Director, Quality Assurance (Gene Therapy Program)

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Executive Director, Quality Assurance (Gene Therapy Program)

 


University Overview

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.

Posted Job Title
Executive Director, Quality Assurance (Gene Therapy Program)

Job Profile Title
Director E

Job Description Summary
The Gene Therapy Program (GTP) is entering a new era of unprecedented opportunity with 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

Job Description

As an Executive Director of Quality Assurance, you will provide professional expertise and leadership in the Quality function as it relates to viral vector manufacturing oversight for our GMP/GLP operations. This role is expected 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.

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 provide guidance for creating, implementing and improving quality processes across all platforms and work with our CDMO partners to ensure they have the appropriate quality systems in place and to provide quality oversight of manufacturing activities. This will be in addition to managing and supervising, including mentoring, the QAU. This role will also be expected to coordinate implementation and management of the QAU across GTP facilities and laboratories, ensuring that GTP remains up-to-date on all regulations and guidelines related to gene therapy. There will be heavy involvement with key leaders to gain alignment for continuous improvement and relationship building.

Qualifications:

 

 

  • MS relevant scientific field or discipline, 10+ years experience (management experience preferred) and strong scientific background in biologics manufacturing and Quality Assurance in the drug development industry with strong knowledge of cGMP/ICH/FDA/EMA regulations required. (PhD Preferred)
  • Prior experience in Quality for biologic products as well as oversight of Quality in an industrial setting preferred.
  • Successful experience writing and reviewing SOPs and other Quality documents.
  • Direct experience with quality investigations, assessments, reviews and/or evaluations of Quality events (CAPAs, deviations, change control, document control, etc.).
  • Team player with the ability to work in a collaborative, fast-paced team environment.
  • Strong written and verbal communication skills and experience with working in cross-functional teams.
  • Strong leadership skills and strategic problem-solving ability; ability to predict issues and identify solutions.
  • Excellent problem-solving skills and experience with root cause investigations and CAPA determination.
  • Ability to lead successfully within extended project teams and handle multiple challenges under pressure.
  • Excellent communications and presentation skills, written and verbal.
  • Excellent organizational skills: Proactive, management of multiple tasks of varying complexity simultaneously.

 


Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$108,411.00 - $205,981.00

Affirmative Action Statement
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.

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.

University Benefits

 

 

  • Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
  • Tuition: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
  • Retirement: Penn offers generous retirement plans to help you save for your future. Penn's Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
  • Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.
  • Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you're newly hired, you won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
  • Wellness and Work-life Resources: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That's why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
  • Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
  • University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University's libraries and athletic facilities, or visit our arboretum and art galleries. There's always something going on at Penn, whether it's a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you're right in the middle of the excitement—and you and your family can enjoy many of these activities for free.
  • Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
  • Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
  • Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
  • Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.




To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay


To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Translational-Research-Laboratories/Executive-Director--Quality-Assurance--Gene-Therapy-Program-_JR00038910





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