Hybrid Clinical Systems Quality Manager

Posted 5 hours ago

Apply now

About the role

  • 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)
  • retirement benefits, including 401(k)
  • paid holidays
  • vacation
  • compassionate and sick days

Job title

Clinical Systems Quality Manager

Job type

Experience level

Mid levelSenior

Salary

$114,700 - $180,500 per year

Degree requirement

Bachelor's Degree

Location requirements

Report this job

See something inaccurate? Let us know and we'll update the listing.

Report job