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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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
Position Type Full Time
Position Schedule 8-5pm
Position Length Contingent Upon Funding
Position End Date
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.
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/
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.
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.
Quick Link http://jobs.hr.upenn.edu/postings/39652
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