GxP Systems and Support Administrator

The GxP Systems and Support Administrator is responsible for the lifecycle administration of GxP and Quality governed systems within CAI, including but not limited to the eQMS, CMMS, and Digital Validation systems. The role is within the integrated IT & Information Security team at CAI, with cross-functional reporting to CAI’s Digital & Quality teams.

Key Responsibilities:

• Administer GxP applications supporting infrastructure: Dot Compliance eQMS, Master Control CMMS, Kneat & Valkit Digital Validation Applications.
• Perform user account administration, role-based access control, and periodic access reviews.
• Manage system configuration, upgrades, and patches using established change control & validation processes.
• Maintain validated system state through proper documentation and adherence to validation procedures.
• Deploy & manage project-based instances of Digital Validation applications to support client services.
• Support Computer Software Assurance (CSA) activities including review of vendor testing packages, documented ad hoc testing, execution of System Acceptance Testing and User Acceptance Testing, and Periodic Reviews.
• Participate in the creation, review, and approval of validation documentation, SOPs, work instructions, training materials / requirements, and technical documentation.
• Participate in risk assessments and validation impact assessments for system changes.
• Execute and document system change controls in accordance with Quality Management System (QMS) requirements.
• Investigate, troubleshoot, and resolve system incidents, deviations, and user-reported issues.
• Support CAPA investigations by providing technical analysis and implementing corrective actions.
• Support internal audits, supplier audits, customer audits, and regulatory inspections.
• Ensure audit trails, electronic records, and electronic signatures comply with regulatory requirements.
• Collaborate with vendors to resolve software defects and implement approved upgrades.
• Manage Tier 1 & Tier 2 technical support for applicable systems.
• Assist in cybersecurity initiatives for regulated systems, including vulnerability remediation, security monitoring, and entitlement reviews.
• Train end users on system functionality and compliance requirements.

Qualifications:

Required:

• A Bachelor's degree in Information Technology, Computer Science, Life Sciences, or related field, or equivalent experience.
• 3–5+ years of experience administering IT systems and providing technical support.
• 2+ years of experience administering GxP-regulated systems in a pharmaceutical, biotechnology, medical device, or related regulated environment.
• Experience supporting validated computer systems throughout their lifecycle.
• Working knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity / Good Documentation Practices (GDP).
• Experience collaborating with Information Security & Quality departments to ensure system compliance with internal and regulatory requirements.
• Experience with change management, investigations, deviations, and other Quality-related procedures.
• Experience with Entra identity management, access controls, SSO & SCIM integrations.
• Knowledge of backup, recovery, and disaster recovery procedures.
• Excellent troubleshooting, analytical, and documentation skills.
• Strong communication skills and ability to work with cross-functional teams.

Preferred:

• Experience administering CMMS, DVT, or eQMS platforms in a GxP environment.
• Experience in GxP or Quality systems administration within a Professional Services or consulting organization.