Director, IT – TechOps and Quality

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

This position reports to the Senior Vice President, IT and is a key leadership role responsible for driving and supporting TechOps and Quality programs at Iovance. The Director, IT - TechOps & Quality is responsible for the strategy, implementation, and lifecycle management of enterprise applications that support Technical Operations (Mfg, MSAT, Supply Chain, etc.) and Quality functions within Iovance. This role ensures that GxP systems are compliant, validated, and aligned with regulatory expectations while enabling scalable, efficient, and data-driven operations.  The Director will act as the primary IT business partner to Technical Operations and Quality, ensuring that digital capabilities support clinical and commercial manufacturing readiness.  This is a “hands on” and onsite role that will require system ownership and administration in select cases.

 Primary Responsibilities

• Establish and grow the human and technical infrastructure to continue to build out a high-performing delivery organization at Iovance (in-house, outsourced, or hybrid).
• Work directly with the business functions to formulate strategies, develop plans, and implement operational controls to ensure that the application portfolio meets the needs of the business.
• Possess strong stakeholder management skills and serve as the single point of contact for IT services to the leadership at Iovance’s cell therapy manufacturing facility.
• Monitor the performance of IT services and partner with service delivery teams (external and internal) to drive operational excellence.  Manage relationships with key vendor partners.
• Provide oversight for or own key IT applications supporting TechOps and Quality
• MES, EBR, QMS, LMS, LIMS, etc.
• Quality, Lab & Manufacturing  Instrument applications
• Other process-specific applications
• Ensure systems are compliant with global regulatory requirements (FDA, TGA, etc.)
• Partner with QA on audit readiness and inspection support.
• Establish and build productive relationships with executive leadership and functions as a valued partner and advisor.
• Mentor and grow an organization of technical professionals charged with understanding our core business processes and delivering high-quality software products.
• Be capable of operating effectively along a vast spectrum of responsibilities from strategic decisions to tactical hands-on system administration as needed.
• Work with other IT teams to ensure 24x7 delivery and support per Business Requirements.
• Be accountable for the Budget and Financial Mgmt for the department. 

Qualifications 

• At least 12 years of increasing leadership experience and exposure working in biotech/pharma IT supporting GMP manufacturing and Quality organizations.
• Experience with cell and gene therapies is a significant plus.
• Experience working in a pharmaceutical regulated environment (GxP, FDA).
• Strong interpersonal, facilitation, influencing, presentation, and communication skills.
• Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.
• Project management skills and focus on delivery of results.
• Flexible, adaptable, and hands-on approach necessary (i.e. be the system admin in some cases)
• Hands-on experience with:
• MES / EBR platforms (e.g., Werum PAS-X, Emerson Syncade)
• QMS platforms (e.g., Veeva Vault QMS, MasterControl)
• ERP systems
• Lab instrumentation and associated applications
• Strong understanding of:
• Computer System Validation (CSV) / Computer Software Assurance (CSA)
• Regulatory requirements
• Software Development Lifecycle (SDLC)
• IT Service Management 

Preferred/Desirable Knowledge, Skills, and Education 

• Bachelors or Masters in computer science or relevant degree.

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.
• 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 job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible.  Requires operating standard office equipment and keyboards.

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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.  

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