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Quality Systems Engineer – GAMP5 / GMP
Quality Systems Engineer – GAMP5 / GMPJMD Technologies Inc. • Boston, MA, United States
Quality Systems Engineer – GAMP5 / GMP

Quality Systems Engineer – GAMP5 / GMP

JMD Technologies Inc. • Boston, MA, United States
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Key Responsibilities :

  • Provide quality oversight for enterprise computerized systems, including Veeva, ServiceNow, and ALM .
  • Lead reviews for new system implementations, upgrades, and releases, including deviation and CAPA management.
  • Support data integrity assessments, change control, and system testing oversight.
  • Review and approve system documentation such as test plans, execution results, and quality reports.
  • Identify and mitigate quality and compliance risks during system development and lifecycle management.
  • Ensure adherence to regulatory and data integrity standards (GxP, GMP, GCP, GLP).

Qualifications :

  • Bachelor’s degree in Computer Science, Information Technology, or a related discipline.
  • 5+ years of experience in computerized systems quality, compliance, or QA oversight (non-validation focused).
  • Hands-on experience with Veeva, ServiceNow, ALM , or similar enterprise platforms (QMS, ERP, or workflow management tools).
  • Familiarity with ITIL, GAMP5, and Agile methodologies.
  • Strong understanding of GxP compliance and data integrity principles.
  • Excellent analytical and communication skills; able to collaborate across cross-functional teams.
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    Quality Engineer • Boston, MA, United States