GxP Systems and Support Administrator

About the role

The GxP Systems and Support Administrator is responsible for the lifecycle administration of GxP and Quality governed systems, including eQMS, CMMS, and Digital Validation systems. This role sits within the integrated IT & Information Security team and involves cross-functional collaboration with Digital and Quality departments to ensure system compliance and operational readiness.

Responsibilities

• Administer GxP applications supporting infrastructure including eQMS, CMMS, and 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 and validation processes.
• Support Computer Software Assurance (CSA) activities, including testing execution and periodic reviews.
• Participate in the creation, review, and approval of validation documentation, SOPs, and technical documentation.
• Investigate, troubleshoot, and resolve system incidents, deviations, and user-reported issues.
• Support internal and external audits and regulatory inspections to ensure compliance with electronic record requirements.
• Manage Tier 1 and 2 technical support and assist in cybersecurity initiatives for regulated systems.

Required skills

• IT systems administration
• GxP-regulated systems
• FDA 21 CFR Part 11
• EU Annex 11
• GAMP 5
• Data Integrity
• Change management
• Entra
• Identity management
• SSO
• SCIM
• Disaster recovery

Nice to have

• CMMS
• DVT
• eQMS
• Professional Services

Qualifications

• Bachelor's degree in Information Technology, Computer Science, Life Sciences, or related field
• Equivalent practical experience

Benefits

• Comprehensive Health Insurance
• 24 days of Paid Time Off
• Company paid Life Insurance
• Company paid Long Term Disability

About the Company

CAI is a professional services company established in 1996 that provides accelerated operational readiness and performance for mission-critical and regulated industries. The company operates at the intersection of wisdom and technology, with a focus on integrity and serving society.