Senior Validation Specialist (Boston)

Job Title : Sr. Quality Engineer CSA (VMS Site)

Duration : 24 Months

Work Arrangement : Hybrid (3 days per week onsite in Boston)

Hours / Week : 40

Managers 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 :

Preferred Qualifications :