eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.
OVERVIEW
The Manager, Quality Systems & Operations (QSO) is responsible for leading the day-to-day operation, governance, and continuous improvement of the organization’s Quality Management System (QMS) within a regulated clinical technology environment. This role serves as the operational backbone (“engine room”) of the Quality & Compliance function and ensures quality processes are efficient, inspection-ready, risk-based, and aligned with the needs of a clinical trial software / technology-enabled services organization.
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. This role partners closely with Product, Engineering, Information Security, Operations, Client Services, Audits & Assurance (AA), and Systems & Regulatory Compliance (SRC) to support GxP expectations, customer requirements, and operational excellence.
KEY TASKS & RESPONSIBILITIES
➢ Quality Management System (QMS) Ownership
- Own the administration, maintenance, and continuous improvement of the enterprise QMS supporting a clinical trial software / vendor services environment.
- Manage controlled documentation processes including SOPs, policies, work instructions, templates, validation documentation, and periodic reviews.
- Ensure document control practices meet internal governance, client expectations, and applicable GxP / computerized systems requirements.
- Maintain version control, approvals, archival, training linkage, and retention controls for quality records.
➢ Quality Operations / Day-to-Day Oversight
- 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.
➢ Quality Events, Investigations & CAPA
- 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.
- Facilitate governance reviews for aging items, repeat issues, overdue actions, and systemic trends.
- Support quality investigations involving validated systems, software releases, data integrity concerns, or service delivery issues.
➢ Training Program Support & Effectiveness
- Support administration of the quality training program and learning compliance processes.
- Ensure role-based training matrices align with regulated responsibilities and controlled procedures.
- Provide guidance on training effectiveness assessments, retraining triggers, and onboarding quality training.
- Monitor completion rates, overdue training, and training-related KPIs.
➢ Metrics, KPIs & Management Reporting
- 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.
- Use data to identify improvement opportunities and inform management review activities.
➢ Continuous Improvement / Operational Excellence
- Identify opportunities to streamline, automate, and mature quality processes while maintaining compliance.
- Lead initiatives to improve user experience and adoption of quality systems/tools.
- Support implementation, configuration, or enhancement of electronic QMS (eQMS), LMS, issue management, and workflow tools.
➢ Cross-Functional Partnership
- Partner with Product, Engineering, DevOps, Security, and Operations teams to embed practical quality controls into business processes.
- Collaborate with Audits & Assurance (AA) on internal/external audit readiness, observations, and remediation.
- Collaborate with Systems & Regulatory Compliance (SRC) on GxP requirements, supplier/customer obligations, validation governance, and regulatory commitments.
- Support client due diligence requests, quality questionnaires, and customer audits as needed.
➢ Other duties as assigned
Education & Experience
➢ Bachelor’s degree in Life Sciences, Quality, Engineering, Computer Science, Business, or related discipline preferred
➢ 12+ 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
Professional Skills
➢ 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
Technical Skills
➢ Experience using electronic QMS platforms and workflow systems
➢ Experience with tools such as Qualio, Veeva, MasterControl, TrackWise, Jira, or similar platforms preferred
Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!
eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!
We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.
