Quality Assurance Manager, Validation (Gene Therapy Program)

Quality Assurance Manager, Validation (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 Large Employers in 2023.

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 or a University authorized exemption is a requirement for all positions at the University of Pennsylvania. For more information about Penn's vaccine requirements, visit the Penn COVID-19 Response website for the latest information.

Posted Job Title
Quality Assurance Manager, Validation (Gene Therapy Program)

Job Profile Title
Manager D, Research

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. GTP is a complex R&D organization consisting of research laboratories supported by multiple core functions which provide internal capacity to perform gene transfer studies from basic research through Phase 1 proof-of-concept human trials.

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 Quality Assurance Manager, Validation will provide Quality Assurance oversight and management for qualification activities and validation activities associated with the installation of equipment/systems in support of the Manufacturing and Quality Control operations at the Gene Therapy Program's (GTP) facilities, TRL & Discovery Labs. In this function, the QA Manager will support qualification/validation activities ensuring compliance with internal procedures, current Good Manufacturing Practice (cGMP), and regulatory requirements. Primary focus will be establishing the QA Validation program. Additional responsibilities will include establishing/developing Quality performance measures and communicating/reporting metrics to Senior Management. The QA Manager of Validation will serve as a Subject Matter Expert (SME) in support of all qualification/validation activities (both planned and unplanned) and will liaise with project teams to ensure that validation tasks are completed in accordance with predetermined timelines.

The QA Manager will develop, manage, and support Quality Assurance initiatives associated with the GMP oversight of the Quality Systems. Additional responsibilities will include writing, reviewing, and approving technical documents including protocols, reports, and standard operating procedures; Work with key stakeholders to prepare and plan validation studies in support of ongoing validation programs; Assist and support GTP business initiatives by ensuring timely completion of assignments through collaboration with GTP internal departments; Develop, train, manage, and support Quality Associates, clearly delegating project tasks, responsibilities, priorities, and timelines.

Additional duties:

• Responsible for the day-to-day supervision of Quality Associates.
• Assess employee performance and assist in employee development and improvement goals.
• Responsible for development and analysis of key performance indicators/metrics, and quality improvement initiatives.
• Responsible for control of documents.
• Assist in establishing governance documents and processes.
• Work with internal and external partners in a matrix environment ensuring compliance with policies, processes, and procedures.
• Ensure activities/results are performed in compliance with cGMP and associated regulations.
• Serve as member of critical project teams providing Quality Assurance oversight.
• Collaborate with other QA resources to develop, leverage, and share best practices ensuring cross-functional efficiencies.
• Responsible for data-driven development and implementation of Quality Improvement Projects.

This position will support Translational Research Laboratories (TRL) and Discovery Labs (DL) work locations.

Qualifications:

• Bachelor's Degree in relevant discipline and 5 to 7 years of experience working within in Biologics/Pharma industry or (equivalent) industry in a GMP manufacturing organization required. Master's Degree preferred.
  
• Previous management experience; working knowledge of SMART goals.
  
• Working knowledge/experience/oversight of Quality Management Systems (i.e. Quality Manual, document control, document archival, employee training systems).
  
• Prior experience/knowledge of risk assessment/validation/quality systems.
  
• Working knowledge/experience of GxP regulations (GMP/GLP/FDA Guidelines/21 CFR Parts 210 & 211/ICH).
  
• Prior experience with generation of metrics, monitoring key quality systems/KPIs, data analysis, including development and provision of reports for Quality Management review.
  
• Working knowledge/experience with Excel, SmartSheets, and Vizio (preferred).
  
• Knowledge of Veeva QualityDocs (preferred).
  
• Prior experience performing risk management, deviation management, and change management.
  
• Strong organizational and interpersonal skills.
  
• Ability to interact, effectively communicate and collaborate with individuals from all levels of the organization.
  
• Ability to manage multiple priorities in accordance with aggressive timelines.
  

Job Location - City, State
King of Prussia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$61,046.00 - $95,972.00
Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile.

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.
  

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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/Discovery-Labs---Building-27A/Quality-Assurance-Manager--Validation--Gene-Therapy-Program-_JR00064780-1



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