Information Technology GxP and Quality Compliance Analyst

POSITION SUMMARY:This position ensures that Information Technology (IT) systems, processes, and policies comply with applicable legal, regulatory, and internal standards — with primary focus on the GxP environment supporting the company’s Bioanalytical Laboratory, and broader accountability for IT’s contribution to the corporate quality management system (ISO 9001).
The Senior IT GxP and Quality Compliance Analyst partners closely with the Bioanalytical Lab, Quality Assurance, Cybersecurity, Enterprise Systems, and the Senior IT GxP Technical Analyst. The role owns IT’s ISO 9001-aligned processes, documentation, and continual improvement activities, and acts as the escalation point and subject matter expert for IT quality and compliance decisions.
DUTIES AND

RESPONSIBILITIES:

Review and assess IT policies, procedures, and controls to ensure 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 — user requirements, functional and design specifications, IQ/OQ/PQ protocols and reports, traceability matrices, and validation summary reports. Conduct 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 efforts, and ensuring timely closure of audit findings. Serve as 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 MSD’s IT environment, and advise MSD on necessary updates to IT practices as regulations evolve. Author, review, and control IT SOPs, work instructions, templates, and policies, managing periodic review cycles, version control, training assignment, and retirement of superseded documents. Manage IT nonconformities, corrective and preventive actions, 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 preparation, auditor liaison, evidence provision, and closure of nonconformities.
EXPERIENCE AND

QUALIFICATIONS:
Bachelor’s degree in Information Technology, Computer Science, Information Systems, or related discipline; equivalent combination of education and experience considered. Minimum 6 years of experience in IT within a GLP and/or GCLP regulated environment, including at least 3 years in an IT quality, validation, or compliance capacity. Direct experience authoring or approving CSV deliverables and supporting regulatory inspections or sponsor audits. Demonstrated experience acting 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. Experience supporting ISO 9001 certification or surveillance audits, or formal internal auditor training (e.g., ISO 9001 Lead/Internal Auditor), preferred. Experience working in an IT role in a high throughput clinical research organization (CRO) strongly preferred. Experience coaching or mentoring IT staff to support a culture of GxP compliance strongly preferred. Professional certification such as CSQE, CQA, RAC, or formal GAMP/CSV training preferred.
KNOWLEDGE, SKILLS AND ABILITIES: Advanced knowledge of IT governance, risk management, security frameworks, and audit processes applicable to 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, conduct risk assessments, and analyze audit evidence. Skilled in document and record control, SOP authoring, and management of controlled document lifecycles. Ability to define and report meaningful quality metrics and present quality performance to management. Ability to translate regul