Veritas Search Group
Senior Quality Engineer, Digital Systems & Compliance
Veritas Search Group, Boston, Massachusetts, us, 02298
Senior Quality Engineer, Digital Systems & Compliance
Base pay range:
$90.00/hr - $100.00/hr
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 role is responsible for providing quality oversight and ownership of computerized system projects across enterprise, laboratory, and manufacturing environments. This role ensures that all systems and processes align with GxP requirements, data integrity principles, and established quality standards while partnering with cross‑functional teams to support regulatory compliance and continuous improvement initiatives.
Key Responsibilities
Provide quality oversight for computerized systems, including QMS, ERP, Veeva, ServiceNow, EDC, Compass, RIM, data analytics platforms, lab systems, and manufacturing systems.
Lead or participate in discussions for new system implementations, enhancements, quarterly releases, and periodic reviews to ensure quality and compliance.
Review and approve project documentation such as validation plans, test scripts, execution results, traceability matrices, and summary reports.
Evaluate and approve quality events (e.g., deviations, CAPAs) related to computerized systems.
Identify quality risks, propose mitigation strategies, and ensure timely resolution of issues in accordance with compliance standards.
Uphold data integrity principles throughout all project phases and system activities.
Provide high‑level guidance on QMS issues, demonstrating strong understanding of quality system fundamentals and lifecycle management.
Ensure thorough quality assurance throughout the development, testing, and deployment of computerized systems.
QSIM Experience.
Minimum Qualifications
Bachelor’s degree in Information Technology, Computer Science, or a related discipline.
5+ years of experience in computerized systems within GMP-regulated environments.
Background in drug product or drug manufacturing facility operations with lab quality oversight experience.
Familiarity with ITIL and GAMP 5 validation lifecycle methodologies.
Strong analytical, documentation, and communication skills.
Preferred Qualifications
Experience with Veeva, ALM, and ServiceNow platforms.
Comprehensive understanding of GxP (GMP, GCP, GLP) compliance principles.
Demonstrated experience in data integrity assessments.
Knowledge of CSA (Computer Software Assurance) approaches and Agile validation methodologies.
Strong technical writing capabilities and ability to communicate complex concepts clearly.
Please submit your resume and send to recruiters@vsearchgroup.com if you are interested. Thank you!
#J-18808-Ljbffr
$90.00/hr - $100.00/hr
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 role is responsible for providing quality oversight and ownership of computerized system projects across enterprise, laboratory, and manufacturing environments. This role ensures that all systems and processes align with GxP requirements, data integrity principles, and established quality standards while partnering with cross‑functional teams to support regulatory compliance and continuous improvement initiatives.
Key Responsibilities
Provide quality oversight for computerized systems, including QMS, ERP, Veeva, ServiceNow, EDC, Compass, RIM, data analytics platforms, lab systems, and manufacturing systems.
Lead or participate in discussions for new system implementations, enhancements, quarterly releases, and periodic reviews to ensure quality and compliance.
Review and approve project documentation such as validation plans, test scripts, execution results, traceability matrices, and summary reports.
Evaluate and approve quality events (e.g., deviations, CAPAs) related to computerized systems.
Identify quality risks, propose mitigation strategies, and ensure timely resolution of issues in accordance with compliance standards.
Uphold data integrity principles throughout all project phases and system activities.
Provide high‑level guidance on QMS issues, demonstrating strong understanding of quality system fundamentals and lifecycle management.
Ensure thorough quality assurance throughout the development, testing, and deployment of computerized systems.
QSIM Experience.
Minimum Qualifications
Bachelor’s degree in Information Technology, Computer Science, or a related discipline.
5+ years of experience in computerized systems within GMP-regulated environments.
Background in drug product or drug manufacturing facility operations with lab quality oversight experience.
Familiarity with ITIL and GAMP 5 validation lifecycle methodologies.
Strong analytical, documentation, and communication skills.
Preferred Qualifications
Experience with Veeva, ALM, and ServiceNow platforms.
Comprehensive understanding of GxP (GMP, GCP, GLP) compliance principles.
Demonstrated experience in data integrity assessments.
Knowledge of CSA (Computer Software Assurance) approaches and Agile validation methodologies.
Strong technical writing capabilities and ability to communicate complex concepts clearly.
Please submit your resume and send to recruiters@vsearchgroup.com if you are interested. Thank you!
#J-18808-Ljbffr