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.
How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether?
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