Director, Quality Assurance Audit (Gene Therapy Program)

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Director, Quality Assurance Audit (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. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Employers By State in 2021.

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.

COVID-19 vaccination is a requirement for all positions at the University of Pennsylvania. New hires are expected to be fully vaccinated before beginning work at the University. For more information about Penn's vaccine requirements and the use of Penn Open Pass, visit the Penn COVID-19 Response website for the latest information.

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

Job Profile Title
Director C

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.

Job Description

The Audit Director role is critical in supporting the delivery of the Quality Assurance Strategies and serving as change agents of the organization's strategic objectives.

The Audit Director will provide leadership, support, and oversight auditors to deliver audits that are responsive to risk, fit-for-purpose, and value-add, meeting the highest level of quality standards. Audit directors build and manage strong partnering relationships with Gene Therapy Program(GTP) stakeholders, often across multiple functions, business units, including partner relationships. They help teams navigate a complex business and risk environment and contentious audit issues, requiring strong organizational awareness, leadership, communication and influencing skills.

The Audit Director establishes the Quality audit program to support both GLP/GMP operations and testing. The Director also leads both internal and external audits for GTP. In this role, the Audit Director builds and manages strong partnering relationships with internal stakeholders and senior Auditee management, and is an integral and active member of relevant governance fora.

The Audit Director regularly requires active participation in complex audits to support the agreement of key messages and advocate on risks and controls. Whatever the assurance product, the Audit Director has responsibility for the quality standards of the work, its records, and the proficiency of the team.

Through the above modes of engagement, the Audit Director will contribute to assurance strategies within the organization as well as with our external partners. These strategies provide the basis for future audit work and, in turn, assurance to the governing board level oversight committee.

Qualifications:

  • Master's Degree and 5 to 7 years of experience or equivalent combination of education and experience is required. Preferably Master's or Bachelor's Degree in Sciences or Engineering with applied Quality industry experience. Experience in a pharmaceutical or biotechnology company is a plus
  • ASQ auditor certification
  • Exceptional knowledge in product regulatory requirements
  • In-depth working knowledge of US and worldwide GxP regulations
  • Ability to build positive relationships to foster a collaborative approach to proactive compliance activities
  • Ability to identify emerging trends in assurance and internal controls through scanning the internal and external business and risk environment
  • Ability to prioritize multiple priorities, projects, and team members, as well as adapt to changing business needs
  • Excellent communication skills; including technical writing and presentation skills
  • Demonstrated teamwork and mediation skills; ability to work through conflicting situations
  • Ability to broker a strategic position after taking feedback from multiple sources
  • Experience driving decision making
  • Ability to succinctly communicate level of risk, priority, or impact to the business

    Job Location - City, State
    Philadelphia, Pennsylvania

    Department / School
    Perelman School of Medicine

    Pay Range
    $74,476.00 - $117,086.00

    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/Quality-Assurance-Audit-Director--Gene-Therapy-Program-_JR00053912-1

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