Senior Quality Engineer - GMP & Validation Leader

Verista; Boston (MA); On-site; USD 70,491 - 113,521; Full time

Benefits offered by this job

Competitive pay

401(k) Retirement Plan (Employer match

Tuition Reimbursement

Paid Time Off & Holidays

Job summary

Verista in Boston, MA is seeking a Senior Quality Engineer to provide QA oversight for GMP manufacturing, validation, and CAPA across Cell & Gene Therapy operations. You will collaborate with Manufacturing, Validation, Engineering, Facilities, and Laboratory teams to ensure compliance throughout the product lifecycle.

The role requires strong knowledge of cGMP, experience leading investigations, and reviewing validation documentation; onsite in Boston, MA with competitive salary and benefits.

Qualifications

• Master's degree or Bachelor's with extensive QA/validation experience in regulated environments.
• Experience providing QA oversight of GMP manufacturing operations.
• Experience supporting validation programs and capital projects within regulated pharma/biotech/Cell & Gene Therapy.

Responsibilities

• Provide Quality Assurance oversight for GMP manufacturing operations across clinical and commercial products.
• Partner with Manufacturing, Validation, Engineering, Facilities, Laboratory Operations, Materials Management, and Capital Projects to ensure GMP compliance.
• Represent Quality on cross-functional project teams as the primary QA resource for initiatives.
• Identify compliance risks and communicate quality gaps with practical, risk-based solutions.
• Review validation protocols/reports, equipment/utility/facility qualification docs, risk assessments, and engineering change documentation.
• Support commissioning, qualification, and validation activities for manufacturing equipment and facilities.

Skills

Root Cause Analysis

Quality Assurance

GMP

Validation

CAPA

Investigations

Change Controls

Cross-functional Collaboration

Education

Master's degree in Engineering, Life Sciences, Scientific, or related

Bachelor's degree in Engineering, Life Sciences, Scientific, or related

Tools

Veeva

Nuvolo

ViewLinc

Job description

Verista in Boston, MA is seeking a Senior Quality Engineer to provide QA oversight for GMP manufacturing, validation, and CAPA across Cell & Gene Therapy operations. You will collaborate with Manufacturing, Validation, Engineering, Facilities, and Laboratory teams to ensure compliance throughout the product lifecycle.

The role requires strong knowledge of cGMP, experience leading investigations, and reviewing validation documentation; onsite in Boston, MA with competitive salary and benefits.