Senior Validation Specialist (Boston)Compliance Group Inc • Boston, MA, United States

No longer accepting applications

Senior Validation Specialist (Boston)

Compliance Group Inc • Boston, MA, United States

7 days ago

Job type

Full-time

Job description

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 :

Bachelors 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.

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Validation Specialist • Boston, MA, United States