IT Business Systems Analyst (Quality Systems)

Location: USA - NC - Remote

Company

hirify.global operates in the biopharmaceutical industry and supports regulated Quality operations through compliant business systems.

What you will do

• Lead requirements gathering, process mapping, gap analysis, and solution design for Quality Systems such as eQMS, CAPA, Deviations, Change Management, and Audit Management.
• Translate business and regulatory requirements into functional and technical specifications.
• Support system validation, including validation planning, risk assessments, IQ/OQ/PQ, change control, and regulated software lifecycle activities.
• Manage implementations, upgrades, enhancements, integrations, and decommissioning across complex multi-region or multi-site initiatives.
• Act as a Quality Systems subject matter expert during audits and inspections, and advise Quality leadership on system capabilities and roadmaps.
• Lead cross-functional workshops, mentor junior analysts, and support data governance, reporting, and Quality metrics analytics.

Requirements

• Bachelor’s degree in Information Systems, Engineering, Life Sciences, or a related discipline.
• 6–10 years of business systems analysis experience, including 4–6 years supporting GxP-regulated Quality Systems in the pharmaceutical or biotechnology industry.
• Experience with eQMS platforms such as Veeva Vault QMS, TrackWise, or MasterControl.
• Strong knowledge of system validation, regulated software development lifecycle methodologies, biopharmaceutical Quality processes, and regulatory expectations.
• Working location: USA - NC - Remote.
• Strong analytical, documentation, communication, and problem-solving skills, with experience in global, matrixed organizations.

Nice to have

• Advanced degree or certifications such as CBAP, PMP, CSV, or ITIL.
• Experience with EtQ and Computer Software Assurance.
• Familiarity with FDA 21 CFR Part 11, Annex 11, and global regulatory expectations.

Culture & Benefits

• Senior individual-contributor role with a high degree of autonomy and minimal supervision.
• Opportunity to work with Quality, IT, and business stakeholders in a global, matrixed environment.
• Focus on process automation, standardization, system integration, and continuous improvement.
• Employment with hirify.global as a full-time position.