Director, IT GxP Systems (25004-B-688-IS)

Company: Arsenal Biosciences
Location: Hayward
Posted on: March 12, 2025

Job Description:

WHO WE AREArsenal Biosciences Inc. is a clinical stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We are seeking a talented and experienced Director, IT GxP Systems to work onsite based in our Hayward office.ArsenalBio's mission and purpose is very clear: defeat cancer. With our programmable and computationally driven approach, our team is engineering medicines with the goal to attack cancer's inherent multifaceted nature and overcome the challenges of addressing solid tumors with cell therapy.Driven by a collective of diverse experts across multi-scientific disciplines as well as clinical and manufacturing expertise, we are united in our purpose to develop the optimal medicines for improving patients' lives.This means you'll have the opportunity to work with the best talent in the field of cell therapy, and be part of ONE TEAM advancing therapies for patients who need it most.The IT Director for Tech Ops GxP Systems will play a key leadership and contributor role in supporting and driving all IT GxP programs and initiatives within ArsenalBio. This role will design, develop and manage all cross-functional deliverables and stakeholder commitments required to support and maintain the IT Manufacturing systems including ERP, MES, Inventory, CT orchestration systems and automated CGT equipment vendors. This will be a critical role responsible for delivering ArsenalBio's IT Manufacturing technology roadmap, implementing and evolving system SDLC, providing technical support, establishing a support model and ensuring the delivery of IT manufacturing capabilities.WHAT YOU'LL DO

• Develop and manage the portfolio of Tech Ops IT projects. Align IT Manufacturing technology roadmap with Manufacturing strategy, information security, GxP compliance requirements and enterprise IT architecture.
• Comprehensive business understanding of Quality and Regulatory functions within a life sciences organization.
• Deep understanding of the necessary activities required to drive IT compliance to support regulatory filing, regulatory inspection, and commercial launch.
• Knowledge of 21 CFR Part 11, Annex 11, data integrity, and CSV process.
• Significant experience implementing SaaS systems and other software solutions to support regulated life science business processes.
• Serve as a technical subject matter expert to the organization and customers, mapping customer requirements to software capabilities of IT systems ensuring optimal technical implementation.
• Own the System Lifecycle Management of Manufacturing application systems and interfaces.
• Lead the development of Service Agreements, Maintenance Agreements, Operating level agreements to enable end to end IT support delivery.
• Lead the requirements collection, definition phase and the design of software solutions while working within defined enterprise architecture in collaboration with internal stakeholders.
• Document/diagram functional process flows to ensure optimization and synchronization of systems.
• Facilitates use case/story boarding for new systems/software or enhancements related to ERP and other manufacturing systems and processes.
• Develop and establish departmental SOPs, qualification/validation protocols and reports with ongoing awareness to changes in business or regulatory.
• Provide technical leadership to project managers, business analysts and programmers working on application/data analytics project teams.
• Work with business owners to formulate and conduct training sessions and teaching materials for propagating enterprise applications knowledge throughout the organization.
• Recommend, schedule, and perform software improvements, patches, upgrades, and/or purchases.WHO YOU ARE
  • Bachelor's degree in IT, CS, Business Process Management or related discipline or equivalent number of years of work experience.
  • Minimum 10 years direct IT experience in roles of increasing responsibility in project/program management, business analysis, or other delivery leadership roles within a life sciences IT organization and 5 years of IT leadership experience.
  • Demonstrated expertise in leading technical projects and implementing complex systems for Cell and Gene Therapy Technical Operations and Manufacturing lines of business.
  • Proven proficiency in managing validated computing environments, encompassing GMP compliance, comprehensive computer system validation, rigorous change management, and systematic discrepancy reporting across regulated manufacturing and scientific operations.
  • Comprehensive expertise in MES, data historian, environmental monitoring, and GMP asset management systems.
  • Ability to support mission-critical business solutions.
  • Extensive expertise in designing and implementing comprehensive IT service management frameworks for mission-critical manufacturing systems.
  • Track record working in a fast paced, highly iterative environment.
  • Strong verbal communication skills and ability to adapt and learn to changing business environment.
  • Experience in Life Sciences with a focus on Cell and Gene Therapy companies is preferred.BENEFITS AND PAYArsenalBio has a generous and comprehensive benefits package that includes medical, dental, and vision as well as mental health resources, virtual and telehealth options, coaching, infertility treatment, parental leave and health savings accounts. We also offer flexible work schedules and flexible time off, which includes two extra "Arsenal Days of Rest" every quarter for employees to recharge.Our people-first culture fosters a deep appreciation for humanity, both in the people we endeavor to serve as well as each other. We are proud to work for a company that is driven by diversity in experiences, ideas and interests, and one that empowers us in an environment that embraces both unity and inclusivity.We are committed to hiring the best talent from diverse backgrounds. A diverse workforce engenders richness of thought, creativity and discovery. We invite individuals who embrace intellectual achievement to bring their unique personal and professional journeys and together we will build transformative cell therapies for cancer patients.We are an equal opportunity employer and value diversity at our company.
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Keywords: Arsenal Biosciences, Hayward , Director, IT GxP Systems (25004-B-688-IS), Executive , Hayward, California