Manager, Quality Systems & Operations

TL;DR

Manager, Quality Systems & Operations (Clinical Tech): Leading day-to-day operation, governance, and continuous improvement of QMS in regulated clinical trial software environment with an accent on efficient, inspection-ready quality processes. Focus on overseeing document control, CAPA management, training support, metrics reporting, and cross-functional process improvements.

Location: Remote

Salary: $120,000 - $150,000 USD

Company

Fast-growing provider of elluminate Clinical Data Cloud platform and expert data services for life sciences organizations worldwide.

What you will do

• Own administration, maintenance, and improvement of enterprise QMS including SOPs, policies, and validation documentation.
• Manage daily quality operations, workflows, escalations, and deliverables like document approvals and CAPA follow-up.
• Oversee quality events, investigations, root cause analysis, and CAPA lifecycle through closure and effectiveness checks.
• Support training program administration, role-based matrices, completion monitoring, and effectiveness assessments.
• Develop quality dashboards, KPIs, trend reports, and use data for management reviews and improvements.
• Lead continuous improvement initiatives, tool implementations, and partnerships with Product, Engineering, Security, and Compliance teams.

Requirements

• Bachelor’s degree in Life Sciences, Quality, Engineering, Computer Science, Business, or related preferred.
• 5+ years in Quality Systems, Operations, or Compliance in regulated environments.
• Experience in clinical trial software, SaaS healthcare tech, CRO, or GxP-supporting organizations.
• Knowledge of GxP principles, data integrity, risk-based quality, CAPA, document control, and training systems.
• Experience with customer/regulatory audits, CSV/CSA, and eQMS tools like Qualio, Veeva, or TrackWise.
• Strong communication, organization, and stakeholder management skills.

Culture & Benefits

• People-first inclusive culture valuing diversity, innovation, learning, and continuous improvement.
• Winner of 2025 Top Workplaces USA Award for Remote Work and Culture Excellence Awards.
• Fast-growing company focused on work-life balance, exceptional vision, and values.
• Opportunities to accelerate skills and career while impacting healthcare future.