Director IT GxP Systems
194k - 238k USD
On-site
Full Time
#Technology
#SAP
#Systems
#Compliance
#Leadership
#Project Management
#Business Analysis
#Regulatory
#Validation
#Management
#Incident Management
Are you ready to join a mission-driven team dedicated to defeating cancer through innovative science? At Arsenal Biosciences, we are a clinical-stage company focused on engineering advanced CAR T-cell therapies for solid tumors. We bring together diverse experts in fields ranging from molecular biology to computational engineering, all united by the goal of improving patients' lives. We invite you to contribute your expertise to our growing team as we push the boundaries of what is possible in cell therapy.
What you bring
As our Director of IT GxP Systems, you will serve as a vital leader in our Hayward, California office. This is a full-time, on-site executive role where you will oversee the technology roadmap for our manufacturing operations. You will be responsible for managing complex systems and ensuring our IT infrastructure supports our life-saving work. Your core responsibilities will include:
- Designing and managing the IT Manufacturing technology roadmap, including ERP, MES, and inventory systems.
- Establishing and evolving the system development lifecycle while ensuring full compliance with GxP standards.
- Leading cross-functional teams to define requirements and implement robust software solutions that support our manufacturing and regulatory goals.
Requirements
We are looking for a seasoned leader with a strong technical background and a deep understanding of life sciences. You should hold a bachelor’s degree in IT, computer science, or a related field, combined with at least ten years of experience in project management or business analysis within a regulated environment. At least five of those years must be in a leadership capacity. You must possess hands-on experience with SAP and a solid grasp of MES architecture. A successful candidate will demonstrate mastery of 21 CFR Part 11, computer system validation, and data integrity. We value individuals who can communicate complex technical solutions in clear business terms and who thrive in a fast-paced, iterative environment. Fluency in English is required.
What we offer
We are committed to supporting your well-being and professional growth, offering a base salary range of $194,000 to $238,000. Our benefits package is designed to care for you both at work and at home, including:
- Comprehensive medical insurance.
- Dental insurance coverage.
- Vision insurance plans.
- Dedicated support for professional development to help you advance your career.
How to Apply
If you are passionate about using technology to advance life-changing therapies, we would love to hear from you. Please submit your application through our official careers portal to be considered for this opportunity. We look forward to reviewing your background and potentially welcoming you to our team.
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