About Iovance Biotherapeutics, Inc.

Iovance Biotherapeutics, Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers. The Iovance TIL platform spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. For more information, please visit www.iovance.com.

Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.

Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on www.iovance.com.

Overview

The Manager, Quality Assurance (QA), IOVA-A QA Ops is responsible for supporting day-to-day GMP QA Operations activities that support manufacturing, testing and release of iPBMCs in a GMP compliant manner. The individual is collaborative, organized, innovative, flexible, with a strong desire to learn and take ownership and accountability.

The Manager provides overall Quality Assurance support including, but not limited to, review

and approval of qualification protocols/reports, validation protocols/report, batch record review and release of manufactured lots. The successful candidate will work on-site and will manage the internal QA Operations team. The Manager is an effective communicator and is comfortable working in a complex and fast-paced environment.

Essential Functions and Responsibilities

Quality Assurance Operational Support:

Ensure that day -to-day activities for QA Operations and lot disposition are efficient, coordinated, and executed as planned.
Ensure efficient operations, and compliance with quality standards, cGMPs, safety regulations, and requirements as documented.
Actively interact with Contract Manufacturing Organizations (CMO), and internal teams to ensure efficient and timely batch release.
Contribute to strategic and tactical decisions based on sound Quality principles and available data. Provide quality direction to, and gain alignment across, functions who are problem solving.
Continuously seek and support new approaches, practices and processes to improve the efficiency and efficacy of the operation.
Perform review and approval of release documentation.
Track and communicate standard work completion and hurdles upward and downward
Author and revise documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc.
Support internal audits and regulatory inspection.

Subject Matter Expertise:

Act as a subject matter expert (SME) and train incoming staff
Maintain comprehensive understanding of current quality assurance processes, as this role is viewed as a subject matter expert. Previous quality assurance experience and familiarity with regulatory requirements for a cGMP facility is required.
Complete accurate, thorough, and timely review and approval of laboratory investigations, deviation investigations, method validations, change controls, and CAPAs.
Ensure that Quality Records (e.g., deviations, laboratory investigations, CAPAs, change controls) are adequately written and closed in a timely manner.

Team Leadership:

Supervision and Development of direct reports, mentoring/coaching to motivate and mentor peers/ staff, to foster a culture of continuous improvement and operational excellence