Information Technology GxP and Quality Compliance Analyst

MSD Careers•Rockville, MD

3d•Hybrid

About The Position

This position ensures that Information Technology (IT) systems, processes, and policies comply with applicable legal, regulatory, and internal standards, primarily in the GxP environment supporting the Bioanalytical Laboratory, and more broadly through IT’s contribution to the corporate ISO 9001 quality management system. The Senior IT GxP and Quality Compliance Analyst partners 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 serves as the escalation point and subject matter expert for IT quality and compliance decisions. The role oversees IT compliance with GLP and GCLP requirements, owns the Computerized System Validation framework, reviews and approves validation deliverables, assesses risks and compliance gaps, and supports audits and regulatory inspections. It also manages IT controlled documentation, nonconformities, corrective and preventive actions, quality metrics, management review inputs, and ISO 9001 certification and surveillance audit readiness.

Requirements

Bachelor’s degree in Information Technology, Computer Science, Information Systems, or a related discipline; an equivalent combination of education and experience is considered.
At least 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 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.
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.
Skill 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 regulatory requirements into practical, proportionate controls that do not impede lab throughput.
Ability to operate 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.
Demonstrated ability to coach, mentor, and upskill others in quality and compliance practices.
Strong written and verbal communication skills, including the ability to explain compliance risks and trade-offs to technical and executive audiences.
Professional presence and strong interpersonal skills for courteous, timely, and diplomatic interaction with all organizational levels, auditors, and inspectors.
Strong attention to detail, critical thinking, and sound judgment when handling ambiguous cross-functional problems with competing priorities.
Continuous-learning mindset and ability to track changes to GxP regulations, data integrity guidance, and quality management standards.
Ability to work independently or collaboratively with cross-functional teams.

Nice To Haves

Experience supporting ISO 9001 certification or surveillance audits, or formal internal auditor training such as ISO 9001 Lead/Internal Auditor.
Experience working in an IT role in a high-throughput clinical research organization (CRO).
Experience coaching or mentoring IT staff to support a culture of GxP compliance.
Professional certification such as CSQE, CQA, or RAC, or formal GAMP/CSV training.

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.
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 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 necessary updates to IT practices as regulations evolve.
Author, review, and control IT SOPs, work instructions, templates, and policies; manage 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 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.