Senior QA Specialist - CQV & Validation Leader

Vertex Pharmaceuticals LLC

Boston (MA)

On-site

USD 79,000 - 90,000

Full time

10 days ago

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Job summary

Vertex Pharmaceuticals LLC in Boston, MA seeks a Senior Quality Specialist to provide QA support for CQV and validation projects at the Vertex Manufacturing Center. You will ensure quality and regulatory compliance for facilities, equipment, and utilities, guiding stakeholders with QA expertise.

This role requires strong project management, leadership, and problem-solving skills to review protocols, manage deviations and CAPAs, and coordinate with Quality Operations, Manufacturing, and Quality

Qualifications

M.S in life sciences and 5-7 years of relevant experience.
B.S in life sciences with 8-10 years of relevant experience.
Experience with GMP manufacturing operations.
Knowledge of cGMP’s and CMC considerations.
Experience with CQV, validation, and regulatory inspections.
Experience with QA documentation systems and QA processes.

Responsibilities

Provide QA oversight for CQV activities across facilities, equipment, and utilities.
Review and approve IQ/OQ/PQ and validation protocols.
Manage deviations, change controls, and CAPAs with cross-functional teams.
Support regulatory inspections and internal audits.
Collaborate with Engineering, Manufacturing, and Quality Control to ensure compliant CQV activities.