Remote eQMS Quality Systems Specialist

McKesson Corporation

Richmond (VA)

Hybrid

USD 83,300 - 138,800

Full time

14 days+

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Job summary

McKesson Corporation is seeking an eQMS System Administrator to configure, validate, and administer the electronic Quality Management System. You will partner with Quality, Regulatory, IT, and stakeholders to develop workflows for Complaints, CAPA, Change Control, Training, Document Control, Audits, and Risk Management, while owning quality system reporting.

You will ensure regulatory alignment, data integrity, and audit readiness, supporting continuous improvement and cross-functional

Qualifications

  • Minimum 4-6 years of experience in Quality Systems or regulated systems administration.
  • Hands-on experience administering and validating an eQMS in a regulated industry.
  • Experience developing workflows and reporting for multiple quality system processes.
  • Bachelor's degree in science, engineering, information systems, or a related field.

Responsibilities

  • Serve as the eQMS System Administrator and Business Process Owner for quality system workflows.
  • Configure, maintain, and optimize eQMS modules, workflows, forms, user roles, and permissions.
  • Ensure system configuration aligns with approved SOPs, regulatory expectations, and data integrity principles.
  • Act as primary liaison between Quality and IT for eQMS-related issues, enhancements, and upgrades.
  • Support system access management, periodic access reviews, and audit readiness activities.
  • Develop, configure, and maintain validated eQMS workflows, including Complaints, CAPA, Change Control, Training, Document Control, Audits, Supplier Quality, Controlled Substances, Risk Management.
  • Author and execute system validation documentation (e.g., URS, FRS, IQ/OQ/PQ, validation summaries).
  • Assess impact of system changes and support change control activities related to the eQMS.
  • Ensure workflows support traceability, escalation, approvals, and regulatory reporting requirements.
  • Design, develop, and maintain QMS reports, KPIs, and dashboards to support Management Review, quality performance monitoring, trending and risk identification.
  • Track and trend quality system metrics (e.g., CAPA aging, complaint trends, training compliance, audit findings).
  • Analyze data to identify systemic issues and continuous improvement opportunities.
  • Present quality system performance data to Quality leadership and crossfunctional stakeholders.
  • Provide general quality systems SME support (e.g., Document Control, CAPA, Supplier Quality, Validation, Change Control, etc.).
  • Ensure procedures and document workflows comply with document control SOPs and regulatory expectations.
  • Support QMS training programs, including role-based training assignments and effectiveness tracking.
  • Provide end‑user support and troubleshooting related to eQMS workflows and reporting.
  • Support internal, customer, and regulatory audits by providing eQMS records, reports, and system evidence.
  • Ensure eQMS configuration supports compliance with applicable regulations and standards (e.g., FDA, ISO).
  • Participate in inspection readiness activities related to electronic records and data integrity.
  • Support continuous improvement of quality system processes and system usability.

Skills

Analytical skills
Data visualization
Cross-functional collaboration
Regulatory knowledge

Education

Bachelor's degree in science/engineering/information systems

Tools

eQMS platforms
MS Office

Job description

McKesson Corporation is seeking an eQMS System Administrator to configure, validate, and administer the electronic Quality Management System. You will partner with Quality, Regulatory, IT, and stakeholders to develop workflows for Complaints, CAPA, Change Control, Training, Document Control, Audits, and Risk Management, while owning quality system reporting.

You will ensure regulatory alignment, data integrity, and audit readiness, supporting continuous improvement and cross-functional

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