Director, IT GxP Systems at Arsenalbio

Arsenal Biosciences Inc. is a clinical-stage company dedicated to the mission of defeating cancer through the development of programmable cell therapies. We utilize a computationally driven approach to engineer advanced CAR T-cell treatments designed to tackle the complex nature of solid tumors. Our team is composed of diverse experts across scientific, clinical, and manufacturing disciplines, all working together to create optimal medicines that improve patient lives. We are currently seeking an experienced Director, IT GxP Systems to join our team at our Hayward office. In this role, you will be a key leader and contributor, driving our IT GxP initiatives and ensuring our manufacturing technology roadmap aligns with our broader organizational goals.

Key outcomes

• Design, manage, and evolve the IT Manufacturing technology roadmap, including systems such as ERP, MES, inventory management, and cell therapy orchestration.
• Oversee the full system lifecycle management for manufacturing applications and their associated interfaces.
• Establish and maintain departmental standard operating procedures, validation protocols, and qualification reports while remaining responsive to regulatory changes.
• Lead the development of service and maintenance agreements to ensure robust, end-to-end IT support delivery.
• Provide technical leadership to project managers, business analysts, and programmers, ensuring that complex solutions are communicated effectively to stakeholders.
• Facilitate the definition and design of software solutions, ensuring they integrate seamlessly with our enterprise architecture.
• Collaborate with business owners to develop training materials and conduct sessions that propagate knowledge of enterprise applications across the company.

Requirements

• A bachelor’s degree in IT, computer science, business process management, or a related field, or equivalent professional experience.
• At least 10 years of direct IT experience in roles of increasing responsibility, including a minimum of 5 years in an IT leadership capacity.
• Proven expertise in the life sciences sector, specifically with GMP environments, computer system validation, change management, and discrepancy reporting.
• At least 5 years of hands-on experience implementing and working with SAP.
• Strong technical understanding of MES systems architecture, including installation and version management.
• Demonstrated ability to design and implement management frameworks for incident, problem, change, release, and configuration management for mission-critical systems.
• Excellent verbal communication skills with the ability to translate complex technical concepts into business value.
• A track record of success working in fast-paced, highly iterative environments.
• Proficiency in English.

Preferred qualifications

• Experience working with GxP applications and good documentation practices.
• Prior experience operating within SOX-audited environments.
• A comprehensive understanding of quality and regulatory functions, as well as clinical operations, biometrics, and drug safety.

Compensation

The estimated base salary for this position ranges from $194,300 to $238,000. Actual offers are determined based on job-related knowledge, experience, education, location, and internal equity. We offer a comprehensive benefits package that includes:

• Medical, dental, and vision insurance.
• Flexible work schedules and remote work options.
• Mental health resources, telehealth options, and coaching.
• Parental leave and infertility treatment support.
• Health savings accounts.
• Dedicated quarterly time off for employee recharging.

How to apply

If you are passionate about advancing transformative cell therapies and meet the requirements for this leadership role, we invite you to submit your application to join our team. We look forward to reviewing your background and discussing how your expertise can contribute to our mission of defeating cancer.