Clinical Systems Quality Manager overseeing quality activities in GxP automated systems compliance. Collaborating with IT and business stakeholders to maintain high standards and effective processes.
Responsibilities
Responsible for performing quality activities as it relates to GxP automated and computer systems compliance within GCD & GRACS.
Works with IT, Business System Owners and the User Community to provide quality services associated with the validation and compliance of automated computer systems.
Act as the quality gate at various project checkpoints.
Manage automated and computer system related quality activities providing consistent quality guidance across GCD and GRACS business areas.
Provide communications/presentations on quality topics surrounding computer validation to Sr. Management, provide validation guidance for GCP computer systems, participate in corporate, departmental audits and regulatory inspections.
Requirements
Bachelor's degree in Computer Science, Computer Information Science or related area.
Five years of end-to-end computer system validation experience required.
Experience in automated or computerized system compliance, project management principles, systems analysis and systems maintenance/support required.
Experience with an automated or computerized system Software Development Life Cycle (SDLC) methodology in a regulatory environment.
Direct experience in quality management, Auditing and supporting Inspections.
Experience in Root Cause Analysis, identification and documentation of appropriate corrective and preventive actions.
Benefits
medical, dental, vision healthcare and other insurance benefits (for employee and family)
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