Quality Systems Engineer – GAMP5 / GMPJMD Technologies Inc. • Boston, MA, United States
Quality Systems Engineer – GAMP5 / GMP
JMD Technologies Inc. • Boston, MA, United States
2 days ago
Job type
- Full-time
Job descriptionBachelor’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.
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 :
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Quality Engineer • Boston, MA, United States
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