University of Pennsylvania QUALITY ASSURANCE & COMPLIANCE MANAGER in Philadelphia, Pennsylvania

QUALITY ASSURANCE & COMPLIANCE MANAGER Below you will find the details for the position including any supplementary documentation and questions you should review before applying for the opening. To apply for the position, please click the Apply for this Job link/button.

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Posting Details

Posting Details

Reference Number 40-29759

Posted Job Title QUALITY ASSURANCE & COMPLIANCE MANAGER

School Name Perelman School of Medicine

Org CI-Center for Cellular Immunotherapy

Posted to the Web 08/27/2018

Posted Job/Salary Grade 028

Employment Type Exempt

Hours N/A

Position Type Full Time

Position Schedule 8-5pm

Months 12

Position Length Contingent Upon Funding

Position End Date

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.

School/Center Overview

The Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education. http://www.med.upenn.edu/

Duties

The Quality Assurance & Compliance Manager will serve as a resident QA subject matter expert in support of CVPF quality related activities (i.e., documents and records control, change control, materials management and product control, facilities management, deviations and incident management, process assurance, metrics and trending, validation, training, QC Lab support etc), and work hand in hand with the QA Director to ensure applicable regulatory and GMP/GLP compliance requirements are met. This individual will drive and enforce the CVPF Quality Policy and Quality Management System (QMS) on behalf of the QA Director. Specific duties include but are not limited to:1. Develop and support departmental strategic goals to assure the highest quality standards and regulatory compliance within the CVPF. Strategic goals include: optimization and simplification of processes while ensuring quality is maintained, fully support CVPF’s Continuous Improvement initiatives, build and maintain a comprehensive training program, act as a Champion of Quality driving change, and enforcing a culture of Quality and Compliance.2. Support the CVPF internal audit program, by conducting internal audits and generating SMART CAPAs to mitigate and/or correct areas of improvement. Support preparations for external audits as well.3. Lead Projects assigned by Director. These may require following the change management process, leading to its implementation using project management tools. 4. Ensure CVPF is up to date with new applicable regulations and standards. Conduct gap assessments against newly published applicable standards and guidelines, and ensure all gaps are addressed and closed in a timely manner.5. Training Program Management – Interface with other Managers to develop and deliver GMP training modules across the CVPF, as applicable. Ensure training program remains robust and compliant. Work with the Training Coordinator(s) to ensure CVPF training curricula is maintained accurate and relevant. Ensure New Hire Training is kept up to date and relevant. Provide ideas on how to keep improving our training program. 6. Responsible for ensuring the CVPF remains compliant with the Annual requirement of GMP training in a timely manner. Preparing training content based on identified areas of improvement. 7. Provide QA oversight and support of CVPF deviations. Review applicable events and lead or coordinate investigations, as needed.8. Author, review and/or approve internal documents (e.g. batch records, CAPAs, SOPs, change controls, validation protocols and reports, etc). 9. In charge of compiling monthly and quarterly compliance metrics’ reports and submit to the QA Director and CVPF management in a timely manner.10. Responsible for the CVPF Quality Management Plan and QMS. This includes generating the CVPF QMS Annual Report and submitting to CVPF management in a timely manner. 11. Provide guidance to the Materials Management, Environmental Monitoring, and Supplier Qualification Programs to ensure they remain compliant.12. Participate in projects assigned by the QA Director.

Qualifications

Minimum Requirements:* Bachelors of Science in a science or related field and at least 5-7 years of experience in Pharmaceutical Quality Assurance and Quality Compliance or an equivalent combination of education and experience required. Masters preferred.* Must have working experience in a GMP facility, as well as sound quality and regulatory principles consistent with ‘best practices.’* Experience in managing deviations and leading investigations is required* Technical writing skills, verbal communication skills, and presentation skills are required.* Knowledge in manufacturing operations, use of manufacturing equipment, process development and Operational Excellence is preferred.* Attention to detail and GDPs are required.* Understanding of statistical techniques is required* Experience creating, supporting, managing change controls is required* Project management skills is required* Working knowledge Quality Management Systems is required.Preferred qualifications:* Experience managing complex projects.* Experience in FDA audits* Knowledge of aseptic processing, and regulatory and industry guidelines and requirements. * Six sigma certification* ASQ certification* Knowledge of manufacture of cell productsIn order to succeed in this role you need to:* Be able to multi-task and prioritize competing tasks.* Be flexible and adaptable to changing priorities. * Comfortable working at a deadline-driven and results-oriented environment. * Flexible to work extended hours including evenings and weekends, if needed.* Be driven and motivated; requiring minimal supervision. Being a team player is critical to the success in this role. * Be a self-starter, comfortable with rapid change, and be an innovator. Able to work with minimal supervision.* Project Management skills are crucial to succeed in this role.* Have excellent communication and interpersonal skills, within all levels of the organization.

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

Quick Link http://jobs.hr.upenn.edu/postings/39652

Posting Supplemental Questions

Required fields are indicated with an asterisk (*).


  • How did you hear about this employment opportunity?

  • Jobs@Penn

  • Contacted by a Penn Recruiter

  • Referred by a Penn Employee

  • Referred by a friend or family member

  • Higher Education Recruitment Consortium (HERC)

  • Inside Higher Ed

  • Indeed.com

  • Other Internet Advertisement

  • Linkedin

  • Twitter

  • Other Social Media Site

  • Professional Affiliation/Trade Website

  • Diversity Association/Publication Website

  • Heard about it at a conference or career fair

  • Apple One

  • Recruitment and/or staffing agency


  • What is your highest level of education completed?

  • Less than high school education

  • High School Diploma or GED

  • Vocational or Technical School

  • Associate's Degree or Two Year College

  • Bachelor's Degree

  • Master's Degree

  • PHD/MD/JD or equivalent doctoral degree


  • How many years of experience do you have related to this position?

  • 0 to 1 Year

  • 1 to 2 Years

  • 2 to 3 Years

  • 3 to 5 Years

  • 5 to 7 Years

  • 7 to 10 Years

  • Over 10 Years

Applicant Documents

Required Documents

  • Resume

Optional Documents

  • Cover Letter