Quality Assurance Regulatory & CMC Manager

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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

Quality Assurance Regulatory & CMC Manager

Job Profile Title

Quality Assurance Manager

Job Description Summary

The Manager of the Regulatory and Cell Manufacturing and Controls (CMC) unit plays a critical role in the regulatory affairs and quality assurance efforts of the Center for Cellular Immunotherapies (CCI). This role will ensure cGMP quality and compliance to release of investigational cell and gene therapy products for human administration manufactured within the Clinical Cell and Vaccine Production Facility (CVPF) at Penn for multiple clinical trials. These trials are early phase I/II first-in-human clinical development to treat subjects with relapsed/refractory cancer, HIV, and other serious diseases under clinical investigation.
The Manager of the Regulatory and CMC unit closely coordinates with CCI Science Operations and the UPenn Office of Clinical Research (OCR) to create and manage the CMC strategy and regulatory compliance for IND applications, including supporting INDs, change controls, clinical product manufacturing data:, and annual reporting to regulatory bodies, and any FDA requests for information.
The Manager of the Regulatory and CMC unit is a supervisory role and will direct a team of 3-4 quality assurance leads and associates to assure highly effective, team-oriented contributors to CVPF's success, and support effective and efficient continuous quality assurance.
Providing quality and regulatory guidance as needed. Working in a highly cross-functional environment under tight deadlines with impact on patients and clinical teams, and with external collaborators/ contacts at biotech companies for providing quality and regulatory support in developing new INDs, clinical protocols, validation plans, and manufacturing products related activities.

Job Description

Job Responsibilities

• Final Review and Disposition (Release/ Reject) of final infusible products for investigational cell and gene therapy products manufactured for first-in-human clinical development at CVPF facility. 
  Quality expert supporting the organization by establishing quality operational processes, quality systems, driving growth, and ensuring quality across cell therapy manufacturing operations. 
  Provides leadership, strategic thinking, and results focus mindset to reliably meet and/or exceed the site’s performance targets and client demands while achieving high levels of quality

• Define and manage CMC strategy for INDs with CCI Research Operations and UPenn Office of Clinical Research (OCR). Assist in preparation and review of IND annual reports including change controls, product manufacturing date , labeling reporting to regulatory bodies Represent CVPF regulatory CMC function to external groups both within UPenn and regulatory and accredited agencies. FDA inquiry responses and IND applications. 
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