Master Compliance
Overview
TITLE/ROLE:
Quality Lead Computerized Systems Quality and Management Long Term General Position Summary
This position will be responsible for supporting the
Quality Information Systems Management (QISM) 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. Responsibilities
Proficient with computerized systems on the enterprise level, ServiceNow, QMS, ERP, Veeva EDC, Compass, RIM, data analytics platforms, lab systems, and manufacturing systems; provide quality oversight on related system projects. Take quality ownership, participate in cross-functional team discussions, provide quality guidance/decisions for projects including new implementations, enhancements, quarterly releases, periodic reviews, and review/approve quality events (deviations & CAPS). Participate in and drive system assessments; review and approve project deliverables, including plans, test scripts, execution, outcome, reports, and traceability. Participate in and drive discussions on issues to resolutions, adhering to quality compliance. Demonstrate sound knowledge of and embrace data integrity integral to system projects. Communicate effectively and work well as a team player. Highlight identified quality risks and present possible mitigation options to the project team, and keep informed of 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 10+ 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 and 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 Job Details
Seniority level:
Mid-Senior level Employment type:
Contract Job function:
Quality Assurance Industries:
Pharmaceutical Manufacturing and Biotechnology Research
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TITLE/ROLE:
Quality Lead Computerized Systems Quality and Management Long Term General Position Summary
This position will be responsible for supporting the
Quality Information Systems Management (QISM) 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. Responsibilities
Proficient with computerized systems on the enterprise level, ServiceNow, QMS, ERP, Veeva EDC, Compass, RIM, data analytics platforms, lab systems, and manufacturing systems; provide quality oversight on related system projects. Take quality ownership, participate in cross-functional team discussions, provide quality guidance/decisions for projects including new implementations, enhancements, quarterly releases, periodic reviews, and review/approve quality events (deviations & CAPS). Participate in and drive system assessments; review and approve project deliverables, including plans, test scripts, execution, outcome, reports, and traceability. Participate in and drive discussions on issues to resolutions, adhering to quality compliance. Demonstrate sound knowledge of and embrace data integrity integral to system projects. Communicate effectively and work well as a team player. Highlight identified quality risks and present possible mitigation options to the project team, and keep informed of 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 10+ 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 and 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 Job Details
Seniority level:
Mid-Senior level Employment type:
Contract Job function:
Quality Assurance Industries:
Pharmaceutical Manufacturing and Biotechnology Research
#J-18808-Ljbffr