Manager, Quality Systems & Operations

Responsibilities

• Own the administration, maintenance, and continuous improvement of the enterprise QMS
• Manage controlled documentation processes including SOPs, policies, and validation documentation
• Oversee quality events including deviations, incidents, and CAPA lifecycle management
• Support administration of the quality training program and learning compliance processes
• Develop and maintain enterprise quality dashboards, KPIs, and trend reports
• Partner with Product, Engineering, and Security teams to embed quality controls into business processes
• Support client due diligence requests and customer audits

Requirements

• Bachelor’s degree in Life Sciences, Quality, Engineering, Computer Science, or Business
• 12+ years of experience in Quality Systems, Quality Operations, or Compliance in a regulated environment
• Experience in clinical trial software, SaaS healthcare technology, CRO, or life sciences technology
• Working knowledge of GxP principles and data integrity expectations
• Experience managing CAPA, investigations, and document control
• Proficiency with electronic QMS platforms and workflow systems

Preferred Qualifications

• ASQ, Six Sigma, ISO, or GxP certifications
• Experience supporting customer audits or regulatory inspections
• Familiarity with CSV / CSA concepts and validation documentation
• Experience with tools such as Qualio, Veeva, MasterControl, TrackWise, or Jira

About the Company

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud.