Clinical IT Quality Control Analyst

McKesson

. Oversee quality control and assurance of software, process, and data integrity validation processes .

Posted 9/17/2026full-timeRemote • North Carolina • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality assurance and validation processes within the pharmaceutical and clinical research sectors, with a strong focus on compliance with GxP and FDA regulations. Proficient in overseeing software validation, quality management, and regulatory requirements while providing guidance to operational teams.

Highest-signal resume keywords

Quality AssuranceGxP ComplianceSoftware Validation21 CFR Part 11Clinical Research Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality ControlData Integrity ValidationValidation Lifecycle DocumentationRisk Management PlansIQ, OQ, PQ ProtocolsValidation AssessmentsSystem Validation PlansData AnalysisReport WritingRegulatory Requirements

Soft Skills

Guidance and SupportCollaborationCommunication

Certifications & Qualifications

Bachelor's Degree

Industry Keywords

GCPCROSMOBiotechPharmaceuticalEU RegulationsAnnex 11GAMP VPIC/SICH

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Oversee quality control and assurance of software, process, and data integrity validation processes
Provide guidance and support to operational teams to ensure compliance with GxP, 21 CFR Part 11, and regulatory requirements
Work with Global Quality and Education, IT QC Specialists, Validation Specialists, Business Owners, Product Owners, and Product Analysts
Support research operations and IT in interpreting corporate and regulatory requirements related to software validation, quality management, and GxP
Oversee quality activities related to software, process, and data integrity validation
Review validation lifecycle documents, including validation assessments, 21 CFR Part 11 assessments, system validation plans, risk management plans, and validation summary reports
Provide quality guidance through preparation, execution, data analysis, and report writing for IQ, OQ, and PQ protocols
Assist with periodic review of system documentation
Provide quality review of changes impacting validated systems and/or processes
Perform other duties as assigned

Requirements

What you’ll need

Bachelor's Degree required; professional qualified experience may be substituted for education
Direct experience in a QA/QC role in computerized systems validation
Experience in GCP clinical space, such as CRO or SMO, highly preferred
3+ years' professional work experience in a clinical research, biotech, or pharmaceutical environment focused on FDA GxP requirements for systems, 21 CFR Part 11, and FDA software validation guidelines
Experience and knowledge of EU regulations, e.g., Annex 11, preferred
Knowledge of industry and international standards for software quality, such as GAMP V, PIC/S, and ICH
Knowledge of pharmaceutical, biologics, CRO, and clinical sites' 21 CFR Part 11 requirements and software validation principles
Must be based in the United States
Visa sponsorship is not available

Benefits

Comp & perks

Comprehensive benefits supporting physical, mental, and financial well-being
Competitive compensation package
Annual bonus or long-term incentive opportunities may be offered
Equity may be included in compensation
Relocation assistance is not available
Visa sponsorship is not available