Director, IT – TechOps and Quality

Iovance Biotherapeutics•Philadelphia, PA

7d•Onsite

About The Position

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.

Requirements

At least 12 years of increasing leadership experience and exposure working in biotech/pharma IT supporting GMP manufacturing and Quality organizations.
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

Nice To Haves

Experience with cell and gene therapies is a significant plus.
Bachelors or Masters in computer science or relevant degree.

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.