IT GXP Quality Compliance Analyst

Title: IT GxP and Quality Compliance Analyst
Location: Rockville, MD (hybrid preferred, open to remote for exceptional candidates)
Type: Direct-Hire
Salary / Pay Rate: DOE

Why Work Here

This is an established life sciences company with a bioanalytical laboratory at the heart of its operations, where getting compliance right directly protects the science. You would be the senior compliance authority within IT, with real ownership over the validation framework, quality processes, and how IT shows up during inspections and audits. The role partners with the lab, Quality Assurance, cybersecurity, and technical teams, so you will have broad visibility and influence across the organization. You would also coach others and help build a culture of GxP compliance. It is a stable, regulated environment that genuinely values quality and continual improvement.

About the Role

This role makes sure IT systems, processes, and policies comply with applicable legal, regulatory, and internal standards, with a primary focus on the GxP environment supporting the company's bioanalytical laboratory and broader accountability for IT's part in the corporate quality management system (ISO 9001). The analyst partners closely with the lab, Quality Assurance, Cybersecurity, Enterprise Systems, and a senior GxP technical analyst who leads lab system delivery. The position owns IT's ISO 9001 aligned processes, documentation, and continual improvement activities. It also serves as the escalation point and subject matter expert for IT quality and compliance decisions, reporting to the IT GRC Program Manager.

Responsibilities

• Review and assess IT policies, procedures, and controls for compliance with Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP).
• Own and maintain the Computerized System Validation (CSV) framework, including validation master plans, risk-based validation strategies, and periodic review schedules.
• Review and approve validation deliverables, including user requirements, functional and design specifications, IQ/OQ/PQ protocols and reports, traceability matrices, and validation summary reports.
• Perform risk assessments and identify GxP compliance gaps or vulnerabilities in IT systems that support the bioanalytical lab.
• Support internal and external audits by preparing evidence, tracking remediation, and making sure audit findings are closed on time.
• Act as the IT point of contact for regulatory inspections and sponsor audits, including hosting inspectors, presenting the IT control environment, and responding to findings.
• Perform periodic self-inspections of IT GxP processes and support qualification and oversight of IT suppliers, SaaS providers, and hosted platforms.
• Maintain compliance documentation, policies, and reports, and provide guidance and training on GxP compliance matters.
• Interpret and apply 21 CFR Part 11, EU Annex 11, GAMP 5, GLP, and GCLP requirements to the IT environment, and advise on needed updates to IT practices as regulations evolve.
• Write, review, and control IT SOPs, work instructions, templates, and policies, managing periodic review cycles, version control, training assignments, and retirement of superseded documents.
• Manage IT nonconformities, corrective and preventive actions (CAPA), and continual improvement initiatives, tracking actions through to verified effectiveness.
• Define, collect, and report IT quality metrics and KPIs, and prepare IT input to management review, including performance against quality objectives.
• Support ISO 9001 certification and surveillance audits for the IT scope, including readiness prep, auditor liaison, evidence, and closure of nonconformities.

Required Skills

• Bachelor's degree in Information Technology, Computer Science, Information Systems, or a related discipline, or an equivalent combination of education and experience.
• 6+ years of IT experience in a GLP and/or GCLP regulated environment, including at least 3 years in an IT quality, validation, or compliance role.
• Direct experience writing or approving CSV deliverables and supporting regulatory inspections or sponsor audits.
• Proven experience acting as an independent approver or quality gatekeeper for computerized systems in a regulated environment.
• Experience running or maintaining an ISO 9001 quality management system, including document control, CAPA, and management review.
• Advanced knowledge of IT governance, risk management, security frameworks, and audit processes in a GLP/GCLP environment.
• Advanced knowledge of GxP compliance requirements for computerized systems, including LIMS, eQMS, and electronic record systems.
• Working knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+ data integrity principles, and supplier qualification expectations.
• Working knowledge of ISO 9001 requirements and quality management principles, including the process approach, risk-based thinking, and continual improvement.
• Ability to interpret complex regulatory frameworks, perform risk assessments, and analyze audit evidence.
• Skilled in document and record control, SOP writing, and managing controlled document lifecycles.
• Ability to define and report meaningful quality metrics and present quality performance to management.
• Ability to turn regulatory requirements into practical, proportionate controls that don't slow down lab throughput.
• Ability to work autonomously as the senior compliance authority in IT, making defensible risk-based judgments with limited precedent or supervision.
• Ability to influence without authority and hold delivery teams to quality and documentation standards.

Bonus / Soft Skills

• Experience supporting ISO 9001 certification or surveillance audits, or formal internal auditor training such as ISO 9001 Lead or Internal Auditor, preferred.
• IT experience in a high throughput clinical research organization (CRO), strongly preferred.
• Experience coaching or mentoring IT staff to build a culture of GxP compliance, strongly preferred.
• Professional certification such as CSQE, CQA, or RAC, or formal GAMP/CSV training, preferred.
• Proven ability to coach, mentor, and upskill others in quality and compliance practices.
• Strong written and verbal communication, including explaining compliance risk and trade-offs to technical and executive audiences.
• Professional presence and strong interpersonal skills, working courteously, promptly, and diplomatically with all levels of the organization, auditors, and inspectors.
• Strong attention to detail, critical thinking, and sound judgment on ambiguous, cross-functional problems with competing priorities.
• Continuous learning mindset, keeping up with changes to GxP regulations, data integrity guidance, and quality management standards.
• Works well independently or with cross-functional teams.

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