GxP Clinical Systems IT Manager

Role Summary

GxP Clinical Systems IT Owner responsible for ensuring clinical IT systems are implemented, validated, and maintained in compliance with applicable regulatory guidelines (FDA 21 CFR Part 11, GAMP 5, EU Annex 11). Reports to the Director, Clinical Systems & Business Intelligence and partners with Quality, Clinical, Regulatory, and external vendors to meet business and compliance requirements throughout the system lifecycle.

Responsibilities

• Lead the planning, execution, and documentation of computer system validation (CSV) activities for clinical applications.
• Collaborate with business owners, QA, and CSV teams to ensure validation deliverables meet GxP and regulatory compliance standards.
• Author and/or review validation documentation including Admin SOPs, Risk Assessments, User Requirements (URS), Test Protocols (IQ/OQ/PQ), etc.
• Create change controls, periodic reviews, and revalidation efforts throughout the system lifecycle.
• Evaluate and manage third-party vendors and SaaS/cloud-based clinical systems for compliance with data integrity and cybersecurity requirements.
• Drive continuous improvement of validation methodologies, templates, and SOPs.
• Support internal and external audits/inspections by providing documentation and demonstrating validation processes.
• Ensure system access, security, backup, and archival procedures meet regulatory and company policies.
• Provide project management support for clinical system implementations and upgrades, ensuring timelines and compliance goals are met while managing multiple projects.
• Monitor emerging regulations, technology trends, and industry best practices for relevance to clinical systems validation.

Qualifications

• Required: Bachelor's degree in Computer Science or related field with a minimum of 4 years of experience in IT/Clinical Systems Validation in Biotech/Pharma.
• Required: Strong understanding of GxP regulations, 21 CFR Part 11, Annex 11, and GAMP 5.
• Required: Hands-on experience with clinical systems validations.
• Required: Proven ability to manage multiple projects and priorities in a regulated environment.
• Required: Excellent communication, leadership, and stakeholder management skills.

Skills

• Regulatory compliance and validation methodologies
• Vendor and SaaS/cloud-based system management
• Documentation and audit support
• Project management and cross-functional collaboration
• Security, data integrity, and backup/archival practices

Education

• Bachelor's degree in Computer Science or related field (Required)