Information Technology GxP and Quality Compliance Analyst

Location: Rockville, MD, United States; hybrid workplace

Annual base salary: $101,400–$154,650, plus potential discretionary or non-discretionary bonus.

Company

hirify.global supports a bioanalytical laboratory environment with regulated information technology systems and quality processes.

What you will do

• Own IT's ISO 9001-aligned processes, documentation, quality metrics, and continual improvement activities.
• Maintain the computerized system validation framework, including validation plans, risk-based strategies, periodic reviews, and approval of CSV deliverables.
• Assess IT systems supporting the Bioanalytical Lab for GLP/GCLP compliance gaps, vulnerabilities, and data integrity risks.
• Support internal and external audits, regulatory inspections, and sponsor audits by preparing evidence, hosting inspectors, responding to findings, and tracking remediation.
• Author and control IT SOPs, work instructions, templates, policies, training assignments, and document review cycles.
• Manage nonconformities, CAPA, supplier qualification, self-inspections, and quality reporting for management review.

Requirements

• Bachelor's degree in Information Technology, Computer Science, Information Systems, or a related discipline; an equivalent combination of education and experience may be considered.
• At least 6 years of IT experience in a GLP and/or GCLP regulated environment, including at least 3 years in IT quality, validation, or compliance.
• Direct experience authoring or approving CSV deliverables and supporting regulatory inspections or sponsor audits.
• Experience serving as an independent approver or quality gatekeeper for computerized systems in a regulated environment.
• Experience operating or maintaining an ISO 9001 quality management system, including document control, CAPA, and management review.
• Advanced knowledge of IT governance, risk management, security frameworks, audit processes, and GxP requirements for systems such as LIMS, eQMS, and electronic records.
• Working knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+ data integrity principles, supplier qualification, and ISO 9001 requirements.
• Ability to interpret regulatory frameworks, conduct risk assessments, analyze audit evidence, define quality metrics, and translate requirements into proportionate controls.
• Ability to operate autonomously, influence without authority, coach others, communicate compliance risks to technical and executive audiences, and work across functions.

Nice to have

• Experience supporting ISO 9001 certification or surveillance audits, or formal ISO 9001 Lead/Internal Auditor training.
• Experience in an IT role within a high-throughput clinical research organization.
• Experience coaching or mentoring IT staff on GxP compliance.
• Professional certification such as CSQE, CQA, or RAC, or formal GAMP/CSV training.

Culture & Benefits

• Work in a traditional office environment or under the stated hybrid model.
• Medical, dental, vision, prescription, flexible spending, disability, life, and accidental death and dismemberment insurance.
• 401(k) plan with company matching, paid vacation, sick leave, holidays, and parental leave.
• Employee assistance program and optional perks including fitness contribution, pet insurance, identity theft protection, and insurance discounts.
• Equal Opportunity/Affirmative Action employer; E-Verify is used to validate candidate work eligibility.