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GxP Quality Systems Engineer

Location: Norwood, Massachusetts
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Job Description

The Role:

Reporting to the Associate Director, Quality Systems, the GxP Quality Systems Engineer will serve as a support of the technical design, development, delivery and maintenance of the GxP Compliance Systems - Quality Management, Document Management, Validation System Management. This position will play a key role in maintaining systems and the integrated processes to support the overall digital / IT QA compliance systems landscape at Moderna.

Here’s What You’ll Do:

  • System administrator support for the day-to-day administration of Veeva Quality Vault and Kneat Validation Management System.
  • Monitor help desk requests and incidents to troubleshoot critical production issues impacting end-users, including system lifecycles, workflows, security settings and object issues.
  • Work directly with the SaaS support teams to bring open service issues to a resolution by triage and monitoring progress.
  • Support issue resolution, continuous process improvements and routine system updates of Veeva Quality Vaults and other compliance systems.
  • Consult with the compliance business areas on development and managed deployment of system enhancements to ensure efficient usage and maintenance of technology.
  • Ensure current system functionality is maintained and assess impact and integrity of introducing new functionality into systems.
  • Support requirement definition and provide technical design insight within the applications and integrations between compliance systems other GxP systems (ERP, LIMS and MES) and Partner Systems.
  • Create and maintain GxP computer system deliverables including user requirements, system specifications and validation test scripts.
  • Perform system sandbox testing and participate in formal system validation testing execution.
  • Assist in system assessments quarterly or yearly to support vendor software releases and patches.
  • Report and management any issues/bugs in the applications to Vendors and assist in troubleshooting and testing.
  • Provide support for planned and unplanned inspections/audits.

Here’s What You’ll Bring to the Table:

  • A bachelor’s degree in science, technology or another relevant academic discipline.
  • 5-8 years of experience implementing and maintaining technology to support GxP QS processes.
  • Excellent interpersonal and communication skills with ability to work collaboratively within a team of stakeholders and influence decisions.
  • Must have a customer service mindset.
  • Quality orientated with strong attention toward details.
  • Ability to interact well with other groups and must be able to take ownership of and follow through on assignments.
  • Self-directed with effective analytical and problem-solving skills. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction.
  • Understanding of industry technology trends in quality management, document management and learning management.
  • Experience with Veeva Vaults (eTMF, Quality (Docs and eQMS). Experience with SAP SuccessFactors learning management, Please Review and Validation Management System (Kneat) is a plus.
  • Understanding of roles and security required when developing or customizing objects.
  • Expertise with computer systems validation practices (GAMP).
  • API, data report development and systems integration.
  • Technical writing skills required.
  • Capable of operating within a fast-moving business environment


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