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0010V5978 Quality Lead/Senior Validation Engineer
0010V5978 Quality Lead/Senior Validation EngineerTwo River Consulting Partners • Boston, MA, US
0010V5978 Quality Lead / Senior Validation Engineer

0010V5978 Quality Lead / Senior Validation Engineer

Two River Consulting Partners • Boston, MA, US
1 day ago
Job type
  • Full-time
  • Quick Apply
Job description
  • FTE OR CONTRACTOR - LONG TERM ASSIGNMENT THROUGH SEPTEMBER 2027
  • SUMMARY This position will be responsible for supporting the Quality Information Systems Management group, working closely with operational functions and other business and QA groups to facilitate regulatory assessments, change control review requirements gathering, design, and system testing.

    • This role will perform quality oversight functions and take quality ownership for all related computerized system projects.

    KEY RESPONSIBILITIES Provide Quality oversight and system proficiency with Enterprise computerized systems- ServiceNow, QMS, ERP, Veeva EDC, Compass, RIM, Data analytics platforms, Lab Systems, and Manufacturing Systems 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 & CAPAs), etc.

    Participate and drive system assessments - review and approve project deliverables, including plans, test scripts, execution and its outcome, reports, and traceability Participate and drive the discussions on issues to resolutions, adhering to quality compliance Highlight any identified quality risks and present possible mitigation options to the project team, and keep them informed of the quality management Perform, evaluate, and communicate thorough quality assurance at every stage of systems development / implementation REQUIREMENTS Bachelor’s degree in IT or Computer Science 5+ years of proven experience with computerized systems, Enterprise Level and Lab systems in the validation / quality space Familiarity with ITIL / GAMP5 Validation Lifecycle Practical experience generating process documentation and reports Excellent communication skills with the ability to translate data into actionable insights 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 LOCATION Boston, MA EMPLOYMENT FTE or Contractor   Powered by JazzHR

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    Validation Engineer • Boston, MA, US