Manager, Quality Systems – Operations
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Job Description
Manager, Quality Systems & Operations at eClinical Solutions overseeing core quality systems and continuous improvement initiatives in a regulated environment.
Responsibilities:
- The Manager, QSO will oversee core quality system processes including document control, SOP lifecycle management, training administration and effectiveness support, quality events and CAPA management, quality metrics and management reporting, and cross-functional process improvement initiatives.
- Serve as operational lead for daily quality system workflows, requests, escalations, and prioritization.
- Ensure timely execution of quality deliverables including document approvals, event reviews, CAPA follow-up, training assignments, and management reporting.
- Coordinate core quality activities across business and technical functions in a fast-paced SaaS / vendor setting.
- Oversee quality events including deviations, incidents, customer quality issues, audit observations, system/process nonconformances, and supplier quality concerns as applicable.
- Manage CAPA lifecycle from initiation through closure, including root cause analysis, action tracking, due dates, evidence review, and effectiveness verification.
- Support administration of the quality training program and learning compliance processes.
- Develop and maintain enterprise quality dashboards, KPIs, and trend reports.
- Report on QMS health including document control cycle times, CAPA status, training compliance, audit observations, quality events, and recurring risks.
- Identify opportunities to streamline, automate, and mature quality processes while maintaining compliance.
- Lead initiatives to improve user experience and adoption of quality systems/tools.
- Partner with Product, Engineering, DevOps, Security, and Operations teams to embed practical quality controls into business processes.
Requirements:
- Bachelor’s degree in Life Sciences, Quality, Engineering, Computer Science, Business, or related discipline preferred
- 5+ years of experience in Quality Systems, Quality Operations, Compliance, or related roles within a regulated environment preferred
- Experience in a clinical trial software vendor, SaaS healthcare technology, CRO, life sciences technology, eClinical, or related GxP-supporting organization
- ASQ, Six Sigma, ISO, GxP, or related certifications preferred
- Working knowledge of GxP principles, computerized systems controls, data integrity expectations, and risk-based quality management
- Experience supporting customer audits, supplier audits, or regulatory inspections preferred
- Experience managing CAPA, investigations, document control, training systems, and quality metrics
- Strong communication, organization, and stakeholder management skills
- Familiarity with CSV / CSA concepts and validation documentation for regulated systems preferred
- Experience using electronic QMS platforms and workflow systems
- Experience with tools such as Qualio, Veeva, MasterControl, TrackWise, Jira, or similar platforms preferred
Benefits:
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
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