GxP Systems and Support Administrator

This is a fully remote position, open to applicants in United States.

📋 Description

• Manage GxP applications that support the infrastructure, including Dot Compliance eQMS, Master Control CMMS, Kneat, and Valkit Digital Validation Applications.

• Oversee user account management, implement role-based access control, and conduct periodic access reviews.

• Handle system configuration, upgrades, and patches by utilizing established change control and validation processes.

• Preserve the validated state of systems through thorough documentation and validation procedures.

• Deploy and oversee project-specific instances of Digital Validation applications to facilitate client services.

• Assist with Computer Software Assurance activities, such as vendor testing package reviews, ad hoc testing, System Acceptance Testing, User Acceptance Testing, and Periodic Reviews.

• Develop, review, and authorize validation documentation, SOPs, work instructions, training materials, requirements, and technical documentation.

• Engage in risk assessments and evaluate the validation impact of system changes.

• Implement and document system change controls in accordance with QMS requirements.

• Investigate, troubleshoot, and resolve incidents, deviations, and user-reported issues related to the system.

• Aid in CAPA investigations through technical analysis and corrective actions.

• Support internal, supplier, customer, and regulatory audits and inspections.

• Ensure that audit trails, electronic records, and electronic signatures adhere to regulatory standards.

• Collaborate with vendors to address software defects and execute approved upgrades.

• Manage Tier 1 and Tier 2 technical support for relevant systems.

• Assist with cybersecurity efforts for regulated systems, including vulnerability remediation, security monitoring, and entitlement reviews.

• Provide training to end users on system functionality and compliance mandates.

⛳️ Requirements

• Bachelor's degree in Information Technology, Computer Science, Life Sciences, or a related field, or equivalent experience.

• 3–5+ years of experience in administering IT systems and delivering technical support.

• 2+ years of experience managing GxP-regulated systems within the pharmaceutical, biotechnology, medical device, or similar regulated industries.

• Proven experience supporting validated computer systems across their lifecycle.

• Familiarity with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity / Good Documentation Practices (GDP).

• Experience collaborating with Information Security and Quality departments to assure system compliance with internal and regulatory standards.

• Proficient in change management, investigations, deviations, and other Quality-related processes.

• Experience with Entra identity management, access controls, SSO & SCIM integrations.

• Understanding of backup, recovery, and disaster recovery procedures.

• Excellent troubleshooting, analytical, and documentation abilities.

• Strong communication skills and a capacity for working with cross-functional teams.

• Preferred: Background in administering CMMS, DVT, or eQMS platforms in a GxP environment.

• Preferred: Experience in GxP or Quality systems administration within a Professional Services or consulting organization.

🏝️ Benefits

• Comprehensive Health Insurance coverage.

• 24 days of Paid Time Off.

• Company paid Life Insurance.

• Company paid Long Term Disability.