Note: The job is a remote job and is open to candidates in USA. Strive Pharmacy is a personalized compounding pharmacy focused on individualized patient care and operates a 503B outsourcing facility. The GMP Systems Administrator will own the site's GMP-regulated computerized systems, ensuring they remain validated, secure, audit-ready and compliant with 21 CFR Part 11, GAMP 5 and data integrity requirements. The role partners with Quality, Engineering, Validation, Operations, IT and vendors across system administration, validation, cybersecurity, access management and change control.
Responsibilities
- Serve as the site's primary technical owner and system administrator for all GMP-regulated computerized systems, including the EMS, BMS, CMMS/CCMS, LIMS, QMS and any EBR or MES platforms
- Ensure all regulated systems maintain a Validated State in accordance with GAMP 5 guidelines; coordinate with Validation on system categorization and risk-based validation approaches
- Maintain and manage audit trails, electronic signature configurations and user access controls on all 21 CFR Part 11-regulated systems, ensuring records meet ALCOA+ standards
- Support the CSV lifecycle: author or review URS, FDS and Configuration Specifications and execute IQ/OQ protocols for new systems, upgrades and patches
- Manage the periodic review program for all validated computerized systems, ensuring scheduled reviews are completed on time and documented in accordance with SOPs
- Participate in Change Control for all IT changes affecting GMP-regulated systems; complete IT impact assessments and ensure no unauthorized changes are made to validated systems
- Implement and maintain cybersecurity controls aligned with FDA cybersecurity guidance for pharmaceutical manufacturing environments; ensure patch management programs do not inadvertently invalidate GMP systems
- Support OT/IT network segmentation that isolates process control systems (BMS, EMS, SCADA, PLC networks) from corporate IT infrastructure, reducing cybersecurity risk to regulated manufacturing systems
- Enforce identity and access management for all regulated systems using RBAC and least-privilege principles
- Maintain secure, GMP-compliant backup, disaster recovery and business continuity procedures for all regulated systems; document and periodically test recovery procedures
- Ensure all electronic records stored in GMP systems are protected against unauthorized modification, deletion or access, in accordance with 21 CFR Part 11 and internal data integrity SOPs
- Evaluate SaaS and enterprise vendors for 21 CFR Part 11 readiness prior to procurement; assess and document vendor controls as part of the supplier qualification process
- Partner with Quality and Procurement to maintain compliant configurations across regulatory submission and track-and-trace tools specific to the 503B environment
Skills
- 4-6 years of progressive IT systems administration experience
- Minimum 2 years of experience working in a GMP-regulated environment (pharmaceutical, biotech, medical device or 503B outsourcing facility)
- Hands-on experience administering computerized systems subject to 21 CFR Part 11 electronic records and electronic signatures requirements, including user access controls and audit trail configuration
- Working knowledge of FDA 21 CFR Part 11 and its practical application to system configuration, audit trails and access controls
- Understanding of data integrity principles as applied to electronic records in a pharmaceutical environment
- Proficiency administering Windows Server and Windows 10/11; comfort supporting vendor-managed appliances and instrument-attached workstations
- Working knowledge of identity and access management tools (Active Directory, Okta or Entra ID) and RBAC concepts
- Clear, disciplined technical writing; this role produces documentation that regulators read
- Experience supporting or executing Computer System Validation (CSV) activities in a regulated pharmaceutical or life sciences environment
- Familiarity with the GAMP 5 V-Model and computerized system risk categories
- Understanding of Change Control processes in a GMP environment; specifically how to assess and document IT changes that may impact validated system states
- Awareness of FDA guidance on cybersecurity for pharmaceutical manufacturing and the ability to apply relevant principles to a 503B site
- Exposure to OT/IT network segmentation in a manufacturing setting
- Scripting or automation skills in PowerShell, Python or Bash
- Bachelor's degree in Computer Science, Information Technology, Information Systems, Engineering or a closely related field; equivalent hands-on experience will be considered in place of a degree
- ISPE GAMP 5 training or equivalent computer system validation coursework
- CompTIA Security+ or CySA+
Benefits
- Remote support and escalation from centralized infrastructure, security and service desk teams.
- Team members who can travel to the site as needed to provide extra hands for larger efforts such as system implementations, upgrade and validation pushes, audit and inspection readiness, equipment installs or coverage during planned and unplanned absences.
- Access to platform owners and subject matter experts for systems that are administered centrally rather than at the site level.
- A dedicated on-site Site Systems Administrator who owns the general IT infrastructure and end-user support for the facility.
- Strive will invest in GAMP 5 and CSV training for the right person.
- Employer-paid healthcare coverage, effective the 1st day of the following month of your hire date
- Free Strive compounded medications for employees based on a valid patient-specific prescription from a licensed healthcare provider
- Paid time off
- Sick time
- FSA and HSA options
- Parental leave
- 401(k) with employer matching
- Life insurance
- Vision and dental insurance
- Veterinary insurance
- Food Truck Fridays and Casual Fridays at the Gilbert, Arizona location
- Holiday potlucks and seasonal gatherings
Company Overview