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Director, IT GxP Systems (24107-R-688-IS)

ArsenalBio

ArsenalBio

IT
Hayward, CA, USA
Posted on Saturday, January 20, 2024
WHO WE ARE
Arsenal 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 the ArsenalBio’s IT Manufacturing technology roadmap, implement and evolve system SDLC, provide technical support, establish a support model and ensure 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. Beneficial to have an understanding of other functions such as Clinical Operations, Biometrics, and Drug Safety.
  • 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 and clear vision for establishing a validation service to GxP stakeholders.
  • 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, and 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 and provide necessary business context into technical design discussions while working within defined enterprise architecture in collaboration with internal stakeholders.
  • Document/diagram functional process flows to ensure optimization and synchronization of systems, including identifying/advising on best applications for specific business processes, including cloud-based 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 as appropriate.
  • 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.
  • Experience with GMP environment, computer system validation, change management, and discrepancy reporting
  • Minimum of 5 years of working experience with SAP including hands on experience implementing SAP.
  • Technical mastery and knowledge of the relevant industry.
  • Strong understanding of concepts of and hands on experience in MES systems architecture, installation and version management.
  • Experience on GxP applications (and good Documentation Practices) and working in SOX audited environments is a plus.
  • Ability to support mission-critical business solutions.
  • Experience designing and implementing Incident, Problem Change, Version, Release, Configuration, Continuity management for mission critical manufacturing systems at a scale.
  • Track record working in a fast paced, highly iterative environment.
  • Should be able to communicate complex solutions and value in business terms. Verbal communication skills are critical and ability to adapt and learn to changing business environment and domains is a must.
  • Experience in Life Sciences is preferred.
BENEFITS AND PAY
ArsenalBio has a generous and comprehensive benefits package that includes but is not limited to 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 have robust tools to help employees take control of their career paths and grow into their best selves. ArsenalBio believes in investing in the well-being of our employees - both at work and at home, as our people are our greatest asset. They bring scientific talents in molecular biology, immunology, pharmacology, protein chemistry, computational biology, automation, genome engineering, software and other fields to make the future happen now.
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. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
The estimated base salary offer for the preferred primary location of San Francisco Bay area ranges from $194,300 – $238,000. Salary ranges for other locations may vary from this range. Base pay offered may vary depending on job related knowledge, experience, education, and location. In addition to these factors, we believe in the importance of pay equity and consider internal equity of our current employees as part of any final offer.
To all recruitment agencies: ArsenalBio does not accept agency resumes. Please do not forward resumes to our jobs alias, or ArsenalBio employees. ArsenalBio is not responsible for any fees related to unsolicited resumes.