Remote GxP Systems & Compliance Administrator

Jobgether SRL

United States

Remote

USD 130,000 - 150,000

Full time

2 days ago
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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

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.

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