Manager Quality Systems & Operations

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. 

You will make an impact: 

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. 

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. 

Your day to day: 

• 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  

Take the first step towards your dream career. Here is what we are looking for in this role. 

Qualifications:  

• 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  

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 is a winner of the 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision values and work-life balance. See all the details here: https://topworkplaces.com/company/eclinical-solutions/ 

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. 

What We Do

At eClinical Solutions our goal is to leverage technology to accelerate clinical research and bring life-changing therapies to patients faster. Our industry-leading elluminate® clinical data platform is used by top life sciences companies worldwide to regain control of their data and provide meaningful analytical insights.

Why Work With Us

Our Engineering team has true greenfield opportunities for software engineers who want to develop innovative revenue-generating products that are revolutionizing the Life Sciences industry. At eClinical Solutions you can make a difference in people's lives while having an exciting and fulfilling career.

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