GxP Systems and Support Administrator

Accountabilities:

• Administer GxP applications and supporting infrastructure, including eQMS, CMMS, and digital validation platforms, while ensuring systems remain reliable, secure, compliant, and fit for purpose throughout their lifecycle.
• Manage user accounts, role-based access controls, SSO and SCIM integrations, periodic access reviews, and entitlement processes to maintain appropriate system access.
• Configure systems and coordinate upgrades, patches, and other technical changes through established change control and validation procedures, ensuring the validated state is maintained.
• Deploy and manage project-based instances of digital validation applications to support client-facing services and operational requirements.
• Support Computer Software Assurance activities by reviewing vendor testing packages, performing documented ad hoc testing, executing System Acceptance Testing and User Acceptance Testing, and conducting periodic reviews.
• Create, review, and support the approval of validation documentation, SOPs, work instructions, training materials, system requirements, and technical documentation.
• Participate in risk assessments and validation impact assessments, and execute and document system change controls in accordance with Quality Management System requirements.
• Investigate, troubleshoot, and resolve system incidents, deviations, and user-reported issues, providing technical analysis and appropriate corrective actions.
• Support CAPA investigations and contribute technical expertise to the identification and implementation of effective corrective and preventive measures.
• Provide technical support during internal and external audits, supplier audits, customer audits, and regulatory inspections, ensuring systems and documentation are inspection-ready.
• Ensure audit trails, electronic records, and electronic signatures are appropriately maintained and aligned with applicable regulatory requirements.
• Collaborate with software vendors to investigate defects, resolve technical issues, and implement approved system upgrades and enhancements.
• Provide Tier 1 and Tier 2 technical support for applicable GxP and Quality systems, while training end users on system functionality and relevant compliance requirements.
• Support cybersecurity initiatives for regulated systems, including vulnerability remediation, security monitoring, backup and recovery considerations, and entitlement reviews.

Requirements

• A bachelor's degree in Information Technology, Computer Science, Life Sciences, or a related field is required, although equivalent professional experience may be considered.
• At least 3–5 years of experience administering IT systems and providing technical support is required, including a minimum of two years administering GxP-regulated systems within pharmaceutical, biotechnology, medical device, or another regulated environment.
• Demonstrated experience supporting validated computer systems throughout their full lifecycle, with a strong understanding of maintaining compliant and validated system states.
• Working knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, Data Integrity, and Good Documentation Practices is required.
• Experience working with Information Security and Quality teams to ensure technology environments meet internal policies and regulatory requirements is essential.
• Proven experience with change management, investigations, deviations, CAPA-related activities, and other Quality procedures is required.
• Hands-on experience with Entra identity management, access controls, single sign-on, and SCIM integrations is required, along with knowledge of backup, recovery, and disaster recovery procedures.
• Strong troubleshooting, analytical, documentation, and problem-solving skills are essential, with the ability to investigate technical issues systematically and maintain accurate records.
• Excellent written and verbal communication skills are required, along with the ability to collaborate effectively across IT, Quality, Information Security, Digital, vendors, and other cross-functional teams.
• Experience administering CMMS, digital validation technology, or eQMS platforms within a GxP environment is preferred.
• Experience administering GxP or Quality systems within a professional services or consulting organization is also preferred.

Benefits

• Base salary range of $130,000–$150,000 per year, excluding benefits.
• Comprehensive health insurance coverage.
• 24 days of paid time off.
• Company-paid life insurance.
• Company-paid long-term disability coverage.
• Remote work arrangement.
• Opportunity to work on mission-critical, regulated technology systems with significant impact on quality, compliance, security, and operational readiness.
• A collaborative and inclusive environment that values diversity, integrity, professional growth, and high-quality work.