Job Description
Job DescriptionJob Summary (List Format):
- Support the Quality Information Systems Management group by collaborating with operational, business, and QA teams.
- Facilitate regulatory assessments, change control reviews, requirements gathering, system design, and system testing.
- Provide quality oversight and assume quality ownership for all computerized system projects.
- Ensure quality compliance and manage quality risks during project implementation and enhancements.
- Participate in cross-functional discussions, offering quality guidance and decisions for system projects (including new implementations, enhancements, releases, and reviews).
- Review and approve quality events (such as deviations and CAPAs), project deliverables, test scripts, and reports.
- Drive system assessments and the resolution of issues related to system quality and compliance.
- Communicate quality risks and mitigation plans to project teams while ensuring ongoing quality assurance throughout all stages of systems development and implementation.
- Leverage expertise in enterprise computerized systems (e.g., ServiceNow, QMS, ERP, Veeva EDC, Compass, RIM, data analytics, lab and manufacturing systems).
- Utilize strong technical writing, communication, and project management skills to deliver innovative and compliant system solutions.