GMP Systems Administrator

Company Overview: Strive Pharmacy is a personalized compounding pharmacy built on a simple conviction: medicine should fit the patient, not the other way around. We started Strive because we believed the pharmaceutical industry was overdue for a more human approach—one that prioritizes individualized care, clinical nuance, and genuine partnership with patients and providers. Compounding gives us the tools to do that. Every formulation we prepare is built to the specific needs of a specific person, and every interaction we have is guided by that same commitment to personalized care. We're growing, and we're looking for people who share that conviction. If you're ready to be part of a pharmacy that takes the work seriously and the people even more seriously, we'd like to meet you. Mission: Strive exists to disrupt an industry long overdue for a more personal approach to care. We put the human element at the center of everything: every formulation, every patient interaction, every provider partnership. We're not just a compounding pharmacy. We're a team on a mission to change what personalized healthcare looks and feels like. Location: Remote (U.S.) – Candidates must be able to travel to our Alachua, FL facility as needed. Preference will be given to those located in Florida or within a short flight. Position Type: Full-Time Schedule: Monday - Friday (day shift) Compensation Range: $110,000 - $120,000 Position Overview: The GMP Systems Administrator is the primary technical owner for all GMP-regulated computerized systems at Strive Pharmacy's 503B outsourcing facility. This role sits at the intersection of IT, OT and pharmaceutical manufacturing compliance, ensuring that every regulated system (including the EMS, BMS, CMMS/CCMS, LIMS and QMS) remains validated, audit-ready and in a continuous state of compliance. This is not a traditional systems administration role. Success requires a working understanding of FDA 21 CFR Part 11 electronic records requirements, GAMP 5 CSV principles and the data integrity standards that govern a regulated pharmaceutical environment. The administrator partners directly with Quality, Engineering, Validation and Operations leadership to keep the site's regulated technology stack compliant and inspection-ready. We are open to candidates who bring strong Part 11 system administration experience and are still building formal validation depth; Strive will invest in GAMP 5 and CSV training for the right person. Key Responsibilities: GMP Computerized Systems Administration 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. GMP Cybersecurity & Data Integrity 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…