Job Description
Note: Only W2 - Not for C2C
Job Title: Sr. Quality Engineer – CSA (VMS Site)
Duration: 24 Months
Work Arrangement: Hybrid (3 days per week onsite in Boston)
Hours/Week: 40
Manager’s Note:
Seeking a candidate with strong GMP and Laboratory Quality experience.
Position Overview:
The Sr. Quality Engineer will support the Quality Information team, collaborating with cross-functional business, operations, and QA groups to ensure compliance and quality oversight of computerized systems across GMP and GxP-regulated environments. The role is responsible for leading and performing quality activities related to system validation, change control, regulatory assessments, and lifecycle management, with a primary focus on applying Computer Software Assurance (CSA) principles to ensure risk-based, compliant validation of laboratory and manufacturing quality systems.
Key Responsibilities:
- Provide quality oversight for enterprise-level computerized systems such as ServiceNow, QMS, ERP, Veeva EDC, Compass, RIM, Data Analytics, Lab, and Manufacturing Systems.
- Apply CSA and GAMP 5 principles to drive efficient, risk-based system validation and ensure compliance.
- Serve as Quality Owner for projects involving new implementations, upgrades, releases, periodic reviews, and CAPA/deviation management.
- Review and approve project deliverables including validation plans, test scripts, execution results, reports, and traceability matrices.
- Lead quality discussions, issue resolution, and ensure adherence to GMP and laboratory compliance standards.
- Demonstrate strong understanding of Lab Quality Systems, Data Integrity, and regulatory expectations.
- Communicate effectively with cross-functional teams to ensure systems align with business and compliance needs.
- Identify quality risks, propose mitigation strategies, and support continuous improvement initiatives.
- Ensure comprehensive quality assurance throughout system development, implementation, and maintenance phases.
Minimum Qualifications:
- Bachelor’s degree in Computer Science, Information Technology, or a related field.
- 8+ years of experience working with computerized systems in GMP-regulated environments.
- Proven expertise in CSA/CSV activities across Enterprise and Lab systems.
- Strong background in Lab Quality, GxP compliance, and risk-based validation.
- Familiarity with ITIL and GAMP 5 validation lifecycle principles.
- Excellent analytical, documentation, and problem-solving abilities.
- Skilled in creating audit-ready documentation, process records, and test evidence.
- Strong communication skills with the ability to translate complex compliance data into actionable insights.
Preferred Qualifications:
- In-depth understanding of computerized system structures and module design.
- Demonstrated experience managing projects and user acceptance testing.
- Ability to design innovative, compliant, and risk-based validation strategies under CSA and GMP frameworks.
- Advanced proficiency in technical writing for regulated environments.
- Experience with Agile validation methodologies.
- Working knowledge of Veeva Vault QMS, ServiceNow, and Application Lifecycle Management (ALM) systems with e-signature functionality.