Manager, IT - GxP Systems & Compliance

Role: IT Manager specializing in GxP Systems & Compliance within a late-stage biotech focused on gene therapies for rare diseases. Responsibilities: provide operational support for GxP manufacturing, QC, and related systems; oversee incident resolution, change control, validation, vendor coordination, and audit readiness; ensure data integrity, security, and compliance with regulations like 21 CFR Part 11 and GAMP 5. Collaborate closely with Manufacturing, Quality, Validation, Automation, and Facilities teams to maintain system uptime, support lifecycle activities, and facilitate audits. Manage system administration tasks including access, backup, patching, and documentation, while supporting continuous improvement initiatives. Qualifications: Bachelor's in IT, Life Sciences, or Engineering; 5-8 years supporting GxP-regulated systems in biotech, pharma, or manufacturing environments; hands-on experience with systems such as LIMS, CDS, MES, BMS, SCADA, Empower, and related regulated applications; deep knowledge of compliance standards (GxP, GAMP 5, 21 CFR Part 11, data integrity). Preferred skills include troubleshooting across applications and infrastructure, strong documentation, and cross-functional collaboration. High-Value: emphasis on regulated validation, audit support, and system lifecycle management in a GxP setting. Work setup involves occasional outside business hours support; physical ability to work in lab/manufacturing environments. Salary range: $120K-$160K, with comprehensive benefits and opportunities for continuous improvement in a collaborative environment.