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# GxP Systems and Support Administrator

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[Apply for this job](#job-application)[View company](https://jobicy.com/company/cai.md)ShareRemote from[USA](https://jobicy.com/job-region/usa.md)SalaryUSD 130k–150k / yrDepartment[DevOps & Infrastructure](https://jobicy.com/categories/admin.md)EmploymentFull TimeExperienceOpen levelPublished7 Oct 2026Apply before6 Nov 2026Listing views41Application actions1Application toolkit

## Make your next move.

Prepare your resume, explore your fit, and draft a cover letter for this opportunity.

AI Summary

## The role, at a glance.

This role administers validated GxP and quality-governed platforms, including eQMS, CMMS, and digital validation systems, within CAI's integrated IT and Information Security function. It combines systems administration, access management, change control, technical support, and lifecycle validation responsibilities in a regulated life-sciences setting. The administrator will support audits, CAPA investigations, software assurance activities, vendor coordination, and end-user training. Success requires practical knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity practices, and identity/access technologies such as Entra, SSO, and SCIM.

## Role DNA

A quick view of the complexity, pace, ownership and collaboration implied by the job description.

### Job Complexity

4/5EasyHard

### Pace & Pressure

4/5RelaxedFast-paced

### Autonomy Level

4/5GuidedFull ownership

### Communication Load

4/5IndependentCollaborative

AI insightThe position requires balancing hands-on platform administration with stringent GxP validation, audit-readiness, and information-security obligations. Errors in access, change control, or documentation can affect compliance, data integrity, and regulated operations.

## Salary analysis

Estimated compensation compared with the broader US market for similar roles.

Estimated job medianHighly competitive$140,000US market range$120k–$160k0$176k

AI insightThe disclosed base salary range is USD 130,000–150,000 yearly, producing a job median of USD 140,000. For a US-based GxP systems administrator with 3–5+ years of IT experience and regulated-platform expertise, an estimated market range is USD 120,000–160,000 yearly; actual market pay varies by location, platform depth, and validation responsibility.

## Core skills

Skills and capabilities most closely associated with this opportunity.

[GxP systems administration](https://jobicy.com/jobs?search_keywords=GxP%20systems%20administration.md)[eQMS](https://jobicy.com/jobs?search_keywords=eQMS.md)[CMMS](https://jobicy.com/jobs?search_keywords=CMMS.md)[computer software assurance](https://jobicy.com/jobs?search_keywords=computer%20software%20assurance.md)[FDA 21 CFR Part 11](https://jobicy.com/jobs?search_keywords=FDA%2021%20CFR%20Part%2011.md)[EU Annex 11](https://jobicy.com/jobs?search_keywords=EU%20Annex%2011.md)[GAMP 5](https://jobicy.com/jobs?search_keywords=GAMP%205.md)[validation lifecycle](https://jobicy.com/jobs?search_keywords=validation%20lifecycle.md)[identity and access management](https://jobicy.com/jobs?search_keywords=identity%20and%20access%20management.md)[technical support](https://jobicy.com/jobs?search_keywords=technical%20support.md)

Sample interview questionsHow do you maintain the validated state of a GxP-regulated application during an upgrade or configuration change?I start by assessing the change's GxP and validation impact, documenting requirements and risks, and following the approved change-control process. I ensure appropriate testing, including vendor evidence review and UAT or SAT where required, is executed and documented before release. I then update validation records, SOPs or training materials as needed, confirm approvals, and retain objective evidence for audit readiness.

What controls would you use to manage user access to an eQMS or digital validation platform?

I would use role-based access control with least-privilege permissions, formal access requests and approvals, and identity controls such as Entra, SSO, and SCIM where supported. I would also perform periodic access reviews, promptly remove access for transfers or terminations, and preserve evidence of approvals and reviews. Any privileged access would receive additional scrutiny and monitoring.

How would you investigate a user-reported system incident that may affect a regulated record?

I would first assess severity, scope, and possible impact on product quality, data integrity, and electronic records. I would preserve relevant audit trails and logs, document the incident under the applicable quality procedure, troubleshoot with the user and vendor as needed, and implement an approved corrective action. If the issue indicates a systemic cause, I would contribute technical evidence to the deviation or CAPA investigation and verify effectiveness.

Describe your approach to preparing a GxP system for an audit or regulatory inspection.

I would confirm that validation documentation, change controls, access reviews, periodic reviews, training evidence, backup and recovery records, and incident or CAPA documentation are complete and readily retrievable. I would review the system's audit-trail settings and confirm that procedures match actual operational practice. I would also coordinate with Quality, IT Security, and system owners to prepare clear, consistent responses and identify remediation items before the audit.

How do you work effectively with Quality, Information Security, business users, and software vendors?

I translate technical issues into risk-based, business-relevant language and establish clear ownership, timelines, and documentation expectations. For each change or issue, I involve Quality early for compliance impact, Information Security for security implications, users for operational requirements and acceptance testing, and vendors for product-specific troubleshooting. This cross-functional approach supports timely delivery without compromising the validated state.

Opportunity details

## About this role.

Are You Ready?

CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For mission-critical and regulated industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years.

Our approach is simple because our Purpose informs everything we do:

We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.

Our Foundational Principles:

* We act with integrity
* We serve each other
* We serve society
* We work for our future

At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity.

For us, operational readiness isn’t simply a goal—it’s a way of life. Tomorrow demands to be at the forefront of today. We get there through tireless effort, precision, efficiency, and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done.

The GxP Systems and Support Administrator is responsible for the lifecycle administration of GxP and Quality governed systems within CAI, including but not limited to the eQMS, CMMS and Digital Validation systems. The role is within the integrated IT & Information Security team at CAI, with cross-functional reporting to CAI’s Digital & Quality teams.

Key Responsibilities:

* Administer GxP applications supporting infrastructure: Dot Compliance eQMS, Master Control CMMS, Kneat & Valkit Digital Validation Applications.
* Perform user account administration, role-based access control, and periodic access reviews.
* Manage system configuration, upgrades, and patches using established change control & validation processes.
* Maintain validated system state through proper documentation and adherence to validation procedures.
* Deploy & manage project-based instances of Digital Validation applications to support client services.
* Support Computer Software Assurance (CSA) activities including review of vendor testing packages, documented ad hoc testing, execution of System Acceptance Testing and User Acceptance Testing and Periodic Reviews. Periodic Reviews
* Participate in the creation, review, and approval of validation documentation, SOPs, work instructions, training materials / requirements, and technical documentation.
* Participate in risk assessments and validation impact assessments for system changes.
* Execute and document system change controls in accordance with Quality Management System (QMS) requirements.
* Investigate, troubleshoot, and resolve system incidents, deviations, and user-reported issues.
* Support CAPA investigations by providing technical analysis and implementing corrective actions.
* Support internal audits, supplier audits, customer audits, and regulatory inspections.
* Ensure audit trails, electronic records, and electronic signatures comply with regulatory requirements.
* Collaborate with vendors to resolve software defects and implement approved upgrades.
* Manage Tier 1 & 2 technical support for applicable systems.
* Assist in cybersecurity initiatives for regulated systems, including vulnerability remediation, security monitoring and entitlement reviews.
* Train end users on system functionality and compliance requirements.

Qualifications:

Required

* Bachelor’s degree in Information Technology, Computer Science, Life Sciences, or related field, or equivalent experience.
* 3–5+ years of experience administering IT systems and providing technical support.
* 2+ Years of experience administering GxP-regulated systems in a pharmaceutical, biotechnology, medical device, or related regulated environment.
* Experience supporting validated computer systems throughout their lifecycle.
* Working knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity / Good Documentation Practices (GDP).
* Experience collaborating with Information Security & Quality departments to ensure system compliance with internal and regulatory requirements.
* Experience with change management, investigations, deviations and other Quality-related procedures.
* Experience with Entra identity management, access controls, SSO & SCIM integrations.
* Knowledge of backup, recovery, and disaster recovery procedures.
* Excellent troubleshooting, analytical, and documentation skills.
* Strong communication skills and ability to work with cross-functional teams.

Preferred

* Experience administering CMMS, DVT or eQMS platforms in GxP environment
* Experience in GxP or Quality systems administration within a Professional Services or consulting organization

#LI-MV1

### Compensation

Average base salary range – not including benefits.

CAI Benefits:

•Comprehensive Health Insurance coverage

•24 days of Paid Time Off

•Company paid Life Insurance

•Company paid Long Term Disability

### Additional Information

We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society.

This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).

Show more

[Apply now >](https://jobicy.com/jobs/154799-gxp-systems-and-support-administrator.md)

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