Manager, Quality Assurance Operations

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  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  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

• Ensure that QA staff are adequately organized, supervised, and Intervene, where necessary, to expedite decision making or to meet target timelines.

• Fully trained in QA processes to enable hands-on assistance when necessary.

• Establish objectives and conduct performance reviews, monitoring progress toward objectives and provide timely feedback to Management.

• Ability to work under limited supervision and to handle problems of a more difficult nature.

General:

• Ability to identify and resolve quality issues with others in a proactive, diplomatic, flexible, and constructive manner.

• Proficiency in generation and monitoring of departmental performance metrics

• Ability to effectively manage multiple changing priorities involving aggressive timelines at a high level of productivity. High level of ownership and accountability.

• Experience with use of an electronic QMS

• Proficient with Microsoft Office Suite, Word, Excel, and Powerpoint

• Must adhere to Iovance Biotherapeutics core values, policies, procedures and business ethics.

• Perform other duties as assigned.

Required Education, Skills, and Knowledge

• Minimum BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or related technical field from an accredited university or college

• Minimum of 8 years of experience in biopharmaceutical based GMP quality operations, including experience in cell culture.

• At least 5 years of Lead/Leadership/Supervisory experience in QA roles, preferably within a manufacturing facility.

• Comprehensive understanding of current quality assurance processes, as this role is viewed as a subject matter expert within specific Significant quality assurance experience and a thorough understanding of regulatory requirements for a cGMP facility is required.

• Experience leading “development” initiatives, e., training, coaching, learning initiatives

• Ability to mentor and provide best practices and support to all teams within the Quality Assurance department.

• Clear and effective collaboration, communication, listening and writing Strong technical writing ability required.

• Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.

• Quality mindset, working knowledge of Code of Federal Regulations 21 CFR 210/211 and standard GxP best practices and FDA regulations.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.

• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.

• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.

• Must be able to perform cleanroom gowning and pass gowning

• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.

• Must be able to communicate with others to exchange information.

Mental

Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.

Work Environment:

This position will work in both an office and a manufacturing setting. When