Senior CQV Quality Lead (GMP & Validation)

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 163,328,000 - 186,252,000; Full time

Job summary

Vertex Pharmaceuticals LLC seeks a Senior Quality Specialist to provide QA support for commissioning, qualification and validation (CQV) at the Vertex Manufacturing Center in Boston, MA. You will ensure quality systems across facilities, equipment, and utilities, guiding stakeholders and maintaining manufacturing integrity.

The role requires strong leadership, regulatory knowledge, and the ability to drive CAPA/deviation management with cross-functional teams.

Qualifications

• MS in life sciences with 5–7 years of relevant experience or BS with 8–10 years of experience.
• Experience providing QA support and oversight of GMP manufacturing operations.
• Experience with drug product development and manufacturing in a pharmaceutical setting.

Responsibilities

• Provide QA oversight for CQV activities and ensure GMP compliance.
• Review qualification/validation plans, protocols, and reports for accuracy and compliance.
• Author and manage QA records including deviations, change controls, and CAPAs.
• Collaborate with Engineering, Manufacturing, and Quality Control to ensure CQV success.
• Support regulatory inspections and internal audits with QA documentation.

Skills

Quality Assurance

CQV

Regulatory compliance

CAPA management

Deviation management

GMP knowledge

Cross-functional collaboration

Education

MS in life sciences

BS in life sciences

Tools

TrackWise

Oracle

Job description

Vertex Pharmaceuticals LLC seeks a Senior Quality Specialist to provide QA support for commissioning, qualification and validation (CQV) at the Vertex Manufacturing Center in Boston, MA. You will ensure quality systems across facilities, equipment, and utilities, guiding stakeholders and maintaining manufacturing integrity.

The role requires strong leadership, regulatory knowledge, and the ability to drive CAPA/deviation management with cross-functional teams.