Overview
Skills
Job Details
Job Title:-Quality Information System Management
Job Location:-Boston MA (Hybrid)
Long Term Contract
KEY RESPONSIBILITIES:
- Proficient with Computerized systems on the Enterprise Level, ServiceNow, QMS, ERP, Veeva EDC, Compass, RIM, Data analytics platforms, Lab Systems, and Manufacturing Systems and provide Quality oversight on the related system projects.
- Take Quality ownership, participate in cross-functional team discussions, provide quality guidance/decisions for the projects that include New implementation, Enhancements, Quarterly releases, Periodic reviews, review and approve Quality events (deviations & CAPS), etc.
- Participate and Drive System Assessments, review and approve the project deliverables, including plan, test scripts, execution and its outcome, reports, and traceability.
- Participate and drive the discussions on issues to the resolutions, adhering to quality compliance.
- Sound knowledge of and Embrace Data Integrity integral to the system projects.
- Should possess good communication skills and fit well as a team player.
- Highlight any identified quality risks and present possible mitigation options to the project team, and keep informed of the quality management.
- Perform, evaluate, and communicate thorough quality assurance at every stage of systems development/implementation
MINIMUM QUALIFICATIONS:
Bachelor's degree in IT or Computer Science
5+ years of proven experience in computerized systems, Enterprise Level and Lab systems validation/quality capacity
Familiarization with ITIL/GAMP5 Validation Lifecycle
Proven analytical abilities
Practical experience generating process documentation and reports
Excellent communicator with the ability to translate data into actionable insights
PREFERRED QUALIFICATIONS:
Strong working knowledge of relevant computerized systems module, structure design
Proven capabilities in project and user-testing management
Proven development of innovative and impactful systems solutions
Highly proficient technical writing capabilities
Knowledge of Agile validation lifecycle and methodologies.
Experience with Veeva VQMS, ServiceNow and Application Lifecycle Management with e-signature (ALM) system is highly desirable.
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