Senior quality engineer digital systems compliance

This role requires candidates who are currently authorized to work in the U.S. without sponsorship, and C2C arrangements are not accepted. This role is hybrid.

Position Summary:

The Senior Quality Engineer, Digital Systems & Compliance , is responsible for providing quality oversight of enterprise and laboratory systems throughout their lifecycle. This role partners with cross-functional teams to ensure compliance with regulatory standards, data integrity, and quality assurance requirements across system implementations, enhancements, and reviews.

Key Responsibilities:

• Provide quality oversight for systems such as ServiceNow, QMS, ERP, Veeva Vault, RIM, data analytics, laboratory, and manufacturing systems.
• Lead and participate in system assessments, validation, and testing activities including review and approval of plans, test scripts, and reports.
• Drive resolution of quality and compliance issues, ensuring adherence to GxP and data integrity principles.
• Take quality ownership of system projects including new implementations, upgrades, and periodic reviews.
• Identify and communicate quality risks and develop mitigation strategies.
• Collaborate with cross-functional teams to ensure consistent application of quality and compliance standards.

Minimum Qualifications:

• Bachelor’s degree in IT, Computer Science, or a related field.
• 5+ years of experience in systems quality or validation within enterprise or laboratory environments.
• Familiarity with ITIL and GAMP5 validation lifecycle.
• Strong analytical, documentation, and communication skills.

Preferred Qualifications:

• Knowledge of Agile validation and Computerized System Assurance (CSA) methodologies.
• Experience with Veeva, ALM, and ServiceNow.
• Background in GxP environments (GMP, GCP, GLP).
• Strong technical writing and user-testing management skills.

Please submit your resume and send to [email protected] if you are interested. Thank you!