Senior Quality Engineer, Computerized Systems Quality and Management (Contract)

This position will be responsible for supporting the Quality Information Systems Management (QISM) group at Vertex 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.

Hybrid to Vertex Boston

24 month 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:

• Bachelors 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.

$90-$100/HR

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (Vertex). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation medical benefits fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors including skills competencies experience location and/or being pursued and other job-related factors permitted by addition this role will be eligible for overtime pay in accordance with federal and state requirements

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