--- title: 'Manager, Quality Assurance Operations at Iovance Biotherapeutics' canonical: 'https://feeny.ai/job/manager-quality-assurance-operations-iovance-biotherapeutics-philadelphia-5dnbp2p4550d' type: 'job' last_seen: '2026-11-05' --- # Manager, Quality Assurance Operations at Iovance Biotherapeutics - **Company:** Iovance Biotherapeutics - **Location:** Philadelphia, PA - **Posted:** 2026-10-29 - **Last confirmed live:** 2026-11-05 - **Apply:** https://job-boards.greenhouse.io/iovancebiotherapeutics/jobs/5465506008 ## Job description About Iovance Biotherapeutics, Inc. [Iovance Biotherapeutics](https://www.iovance.com/), 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](https://www.iovance.com/our-science/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](http://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](http://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 - 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 in the lab, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers. #li-onsite The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time. Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com. By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our [Candidate Privacy Notice](https://www.iovance.com/privacy-policy/). ## About Iovance Biotherapeutics ## Company Overview - **One-liner**: Iovance Biotherapeutics is pioneering tumor infiltrating lymphocyte (TIL) cell therapies to develop personalized, one-time treatments for solid tumor cancers. - **Entity Type**: Public (NASDAQ: IOVA) - **Headquarters**: San Carlos, California, USA - **Founded**: 2007 (originally named Lion Biotechnologies, renamed Iovance Biotherapeutics in 2017) - **Founders**: Not publicly available (the company was formed through a merger and rebranding) ## Core Business - **Primary industry**: Biotechnology — Cell Therapy (Immuno-Oncology) - **Target customers**: B2B / B2G — Healthcare providers, clinical trial sites, and ultimately patients with advanced solid tumors (melanoma, non-small cell lung cancer, endometrial cancer, etc.) - **Mission or purpose statement**: To be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer, harnessing the immune system to recognize and attack diverse cancer cells. ## Products & Services - **Lifileucel (IOV-009)**: A one-time, personalized TIL therapy for advanced melanoma. It is the first approved TIL therapy for a solid tumor (FDA approved in early 2024 under the brand name Amtagvi). - **IOV-LUN-202**: An investigational TIL therapy for advanced non-small cell lung cancer (NSCLC) currently in Phase 2 clinical trials. - **IOV-END-201**: An investigational TIL therapy for advanced endometrial cancer currently in Phase 2 clinical trials. - **IOV-4001**: A next-generation, gene-edited TIL therapy (using TALEN technology to inactivate PD-1 expression) for solid tumors, currently in preclinical/early clinical development. - **IOV-3001**: An engineered IL-2 therapy (licensed from Novartis) designed to support TIL therapy efficacy, currently in preclinical development. - **Cell Therapy Manufacturing (iCTC)**: The company operates a 136,000-square-foot, state-of-the-art Cell Therapy Center in Philadelphia, PA, for proprietary GMP manufacturing of TIL therapies. ## Market Standing - **Valuation/Market Cap**: As of early 2026, market capitalization is approximately $2.5–3.0 billion (fluctuates with FDA news and clinical data). Check current price on NASDAQ: IOVA. - **Key Metric (Revenue)**: Iovance generated its first commercial revenue from Lifileucel/Amtagvi in 2024. Annual revenue for 2025 was approximately $180–220 million (estimate based on analyst reports; exact figure not yet fully disclosed). The company is not yet profitable. - **Key Metric (Funding)**: As a public company, Iovance has raised over $1.5 billion through public offerings and debt financings. Notable recent raise: a public offering in 2022 and subsequent at-the-market offerings. - **Notable Investors/Partners**: - Novartis (license partner for IOV-3001) - Major institutional investors (e.g., BlackRock, Vanguard, and several healthcare-focused funds) - Collaborations with major cancer centers for clinical trials (e.g., MD Anderson, Memorial Sloan Kettering, etc.) - **Growth Signals**: - FDA approval of Lifileucel (Amtagvi) in early 2024 — a landmark first-in-class approval for TIL therapy in solid tumors. - Rapid commercial launch and expansion of treatment centers across the U.S. - Multiple ongoing Phase 2/3 trials in large indications (NSCLC, endometrial cancer, frontline melanoma). - Investment in next-generation gene-edited TIL (IOV-4001) and engineered IL-2 (IOV-3001) to improve efficacy and expand addressable patient populations. ## Competitive Advantages - **First-to-market TIL therapy**: Iovance is the only company with an FDA-approved TIL therapy for a solid tumor (Amtagvi for melanoma), giving it a significant head start in manufacturing, commercial infrastructure, and physician education. - **Proprietary manufacturing platform**: The in-house iCTC facility in Philadelphia enables scalable, standardized GMP production of personalized TIL therapies, a major barrier to entry for competitors. - **Broad solid tumor pipeline**: Unlike CAR-T therapies (primarily effective in blood cancers), TIL therapy has shown promise across multiple solid tumor types, providing a large addressable market. - **Polyclonal T cell approach**: The therapy targets a broad range of neoantigens unique to each patient’s tumor, potentially reducing the risk of immune escape compared to single-target therapies. ## Strategic Focus - **Commercial expansion**: Scaling up the launch of Amtagvi for advanced melanoma and expanding treatment center network globally. - **Pipeline acceleration**: Advancing pivotal trials in NSCLC (IOV-LUN-202) and endometrial cancer (IOV-END-201) to secure additional FDA approvals. - **Next-generation innovation**: Developing gene-edited TIL (IOV-4001) to enhance persistence and efficacy, and engineered IL-2 (IOV-3001) to improve the TIL therapy cycle. - **Manufacturing optimization**: Continuing to improve manufacturing efficiency and turnaround time at the iCTC facility to support growing demand and reduce costs. ## Why Work Here - **Mission-driven culture**: The company is deeply patient-centric, with a clear focus on delivering transformative therapies to cancer patients. Employees often cite the meaningful impact of their work as a key motivator. - **Values**: Integrity, agility, innovation, collaboration, and excellence are core to the company’s operating philosophy. The culture emphasizes transparency, teamwork, and high ethical standards. - **Diversity, Equity, and Inclusion**: Iovance has a stated commitment to DEI, recognizing that internal diversity is critical to serving diverse patient populations and driving innovation. - **Remote/Hybrid policy**: Many roles (especially in clinical, medical affairs, marketing, and commercial functions) are remote or hybrid. Laboratory and manufacturing roles are based on-site in Philadelphia, PA (iCTC) or San Carlos, CA (HQ). - **Benefits**: Competitive salaries, annual cash bonuses, long-term incentives (stock options/RSUs), 401(k) with match, Employee Stock Purchase Plan, comprehensive medical/dental/vision (low employee cost), Health Savings Account contributions, paid parental leave, tuition assistance, wellness program (gym discounts), and professional development opportunities. - **Work environment**: Agile and fast-paced, typical of a biotech company at a critical growth stage. The company values data-driven decision-making and encourages employees to bring their best efforts every day. ## Sources 1. [iovance.com](https://www.iovance.com/) 2. [iovance.com - About Us](https://www.iovance.com/about-iovance-biotherapeutics/) 3. [iovance.com - Culture](https://www.iovance.com/culture/) 4. 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