GxP Systems and Support Administrator

Jobgether SRL; United States; Remote; USD 130,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Paid time off: 24 days

Company-paid life insurance

Company-paid long-term disability

Remote work arrangement

Professional growth in regulated tech

Job summary

Jobgether SRL is seeking a GxP Systems and Support Administrator to oversee lifecycle administration and technical support for regulated GxP and Quality systems. You will manage eQMS, CMMS, and digital validation platforms in a compliant state, collaborating with Information Security, Quality, Digital, vendors, and cross-functional teams to ensure inspection-ready systems.

Responsibilities include change control, validation documentation, access management, and Tier 1/2 support.

Qualifications

• Bachelor's degree in Information Technology, Computer Science, Life Sciences, or related field; equivalent experience considered.
• 3–5 years IT systems administration and technical support experience; at least 2 years in GxP-regulated environments.
• Experience supporting validated computer systems lifecycle; maintaining compliant, validated states.
• Knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, Data Integrity, and GDPs.
• Experience with change control, investigations, CAPA, and Quality procedures.
• Hands-on with Entra, SSO, SCIM; backup, recovery, and disaster recovery knowledge.
• Strong troubleshooting, documentation and cross-functional collaboration skills.
• Experience with CMMS, eQMS, or digital validation in GxP environments preferred.

Responsibilities

• Administer GxP applications and infrastructure (eQMS, CMMS, digital validation) in a compliant lifecycle.
• Manage user accounts, RBAC, SSO/SCIM, access reviews, and entitlements.
• Coordinate system upgrades, patches, and changes via change control and validation.
• Deploy project-based instances of digital validation apps for client services.
• Support Computer Software Assurance via vendor testing packages and UAT/SAT.
• Create and review validation docs, SOPs, work instructions, and technical docs.
• Participate in risk and validation impact assessments; document change controls.
• Investigate incidents, deviations, and issues; provide corrective actions.
• Support CAPA investigations and implement corrective/preventive measures.
• Provide audit support (internal, supplier, customer, regulatory) ensuring inspection readiness.
• Maintain audit trails, electronic records, and e-signatures per regs.
• Collaborate with vendors to address defects and upgrades.
• Provide Tier 1/2 support and train end users on system functionality.
• Support cybersecurity initiatives including vulnerability remediation and DR planning.

Skills

Troubleshooting

Documentation

Communication

Collaboration

Problem-solving

IT systems administration

Cybersecurity basics

Regulatory awareness

Education

Bachelor's degree in IT/CS/Life Sciences

Tools

Entra identity management

SSO

SCIM integrations

eQMS

CMMS

Digital validation platforms

Job description

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a GxP Systems and Support Administrator based in United States.

The GxP Systems and Support Administrator will oversee the lifecycle administration and technical support of regulated GxP and Quality systems.
You will help maintain critical platforms such as eQMS, CMMS, and digital validation applications in a compliant and validated state.
The role combines hands-on systems administration, quality processes, cybersecurity, validation, and technical troubleshooting within an integrated IT environment.
You will collaborate closely with Information Security, Quality, Digital, vendors, and cross-functional teams to ensure systems remain secure, reliable, and inspection-ready.
Your work will directly support regulatory compliance, operational continuity, and the successful delivery of technology-enabled services.
You will also contribute to system implementations, upgrades, audits, investigations, and continuous improvement initiatives.
This is an opportunity to make a meaningful impact in a highly regulated environment where precision, documentation, and technical excellence are essential.

• 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.