Sr. Compliance And Quality Analyst

Sr. Analyst, Compliance and Quality - Remote

One of The Select Group's largest healthcare clients is a research institute that is currently working through myriad of different IS initiatives. They are looking to have someone join that team that will act as their Sr. Analyst and function as a communication liaison between the Technology and Data Solutions (TDS) team and quality assurance. This team anticipates, tracks, and responds to help resolve quality incidents related to TDS operations. This team also participates in performance appraisals and hiring initiatives.

Requirements:

• 8+ years of audit, compliance and information systems experience
• Experience in clinical trials
• Understanding of Solution Development Life Cycle (SDLC) processes
• Understanding of GCP
• Project Management skills and team coordination experience
• Ability to provide reliable time estimates and to handle multiple projects at once
• Excellent communication skills as this role will be speaking with internal colleagues and external clients
• Proficiency in leading and participating in audits, including creating and managing CAPA reports
• Thorough understanding of FDA Guidance on general principals of software validation

Responsibilities

• Leads risk assessment sessions related to the SDLC SOP
• Analyze and propose best practices for implementing operational excellence initiatives.
• Leads the team in regulatory audit/ inspection readiness activities.
• Keeps knowledge of current developments and issues/risks both within the technology organization and the IT industry and applies knowledge to audit practices.
• Understands the role of DCRI TDS in the overall corporate strategy and planning and sets objectives aligned with this role.
• Works with DCRI teams to improve validation processes and policies.
• Creates and or procures training content for GXP.
• Consulting on SOP development within the department.
• Proactively identifies and facilitates opportunities to enhance the quality and cost-effectiveness of TDS services across the organization.
• Lead Agile, lean and/ or Six Sigma driven initiatives.

**This position is considered a remote role, however, will be going on site for major testing and GoLive events in late June and September