Quality Systems Engineer - GAMP5 / GMP (Boston)

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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.

Seniority level

Mid‑Senior level

Employment type

Contract

Job function

Information Technology

Industries

Pharmaceutical Manufacturing

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