Senior IT Quality Systems Analyst

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 Director IT Tech Ops and Quality. The Senior Quality Systems Analyst is a hands-on technical and operational lead responsible for the strategy administration support validation and continuous improvement of Quality and Laboratory systems in a GxP-regulated pharmaceutical manufacturing environment. This role serves as a subject matter expert for enterprise Quality systems especially the LIMS and QMS platforms and partners closely with Quality Manufacturing QC Laboratories MSAT R&D IT and other departments to deliver compliant scalable and efficient digital solutions that support product quality data integrity and regulatory commitments.

Essential Functions and Responsibilities

• Lead the selection deployment administration support and continuous improvement of computer-based systems supporting 24x7 Manufacturing Operations Laboratory and Quality Management processes.
• Serve as the subject matter expert and system owner for Quality and Laboratory platforms including LIMS and QMS solutions.
• Perform operational support activities for critical GxP systems including end-user support monitoring troubleshooting issue resolution break-fix activities and performance optimization.
• Lead system lifecycle management activities including configuration upgrades patching change management deviations and maintenance of inspection-ready documentation.
• Architect implement and maintain system integrations and interfaces including laboratory instrument connectivity and data exchange between lab equipment and enterprise applications.
• Lead computer system validation activities in accordance with FDA EMA GAMP 5 and internal quality standards including risk assessments validation planning and execution of IQ/OQ/PQ documentation.
• Ensure compliance with 21 CFR Part 11 Annex 11 ALCOA data integrity principles and other applicable regulatory requirements.
• Drive continuous improvement and digital transformation initiatives that improve operational efficiency audit readiness system reliability and cost effectiveness.
• Support investigations root cause analysis CAPAs and remediation activities related to system issues data discrepancies or process deviations.
• Provide technical leadership mentoring and knowledge sharing across Quality Systems initiatives.
• Must adhere to Iovance Biotherapeutics core values policies procedures and business ethics and perform miscellaneous duties as assigned.

Required Education Skills and Knowledge

• Bachelors degree in Computer Science Engineering Life Sciences or a related discipline.
• 8 years of hands-on experience in biotech pharmaceutical or other regulated life sciences environments supporting Quality Systems LIMS QMS or manufacturing information systems.
• Experience working in a GxP-regulated environment with strong knowledge of computer system validation SDLC and change control processes.
• Strong knowledge of pharmaceutical business processes 21 CFR Part 11 Annex 11 ALCOA data integrity principles and regulatory compliance expectations.
• Hands-on experience with LIMS and QMS platforms including configuration administration workflows and support.
• Experience with laboratory instrument integration interfaces and enterprise system connectivity using file-based integrations APIs web services or middleware.
• Strong interpersonal presentation analytical and communication skills with the ability to work effectively across technical and business teams.
• Demonstrated sense of urgency strong problem-solving capability and ability to work independently as well as collaboratively.

Preferred Education Skills and Knowledge

• Experience with cell and gene therapy or pharmaceutical manufacturing environments preferred.
• Direct experience with platforms such as LabVantage LIMS MasterControl QMS MES Sample Management software and/or CMMS (Blue Mountain) is preferred.
• Experience designing or supporting end-to-end digital lab and quality ecosystems including integrations with ERP ELN CDS or other enterprise systems.
• Technical experience with SQL scripting database management or advanced integration technologies is a plus.
• Experience supporting multi-site or global operations and leading digital transformation initiatives is preferred.
• Relevant certifications in GxP CSV quality systems or related disciplines are desirable.

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.
• 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 operates in a professional environment and 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 individuals 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 .

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