GMP Quality Assurance Leader - Biologics Ops

Vertex Inc.; Boston (MA); Hybrid; USD 95,000 - 142,000; Full time

Job summary

Vertex is seeking an Associate Director, GMP Operational Quality Assurance in Boston to lead day-to-day quality operations across complex programs. This role partners with Product Quality Leads, MSAT, Regulatory Affairs, and external CDMOs to ensure patient safety, product quality, and regulatory compliance.

The role requires extensive experience in cGMP biologics and the ability to mentor teams, analyze quality metrics, and drive CAPA and risk-based decisions.

Qualifications

• Bachelor’s degree in a scientific or allied health field
• Typically requires 8+ years of relevant GMP Quality experience, including leadership of complex quality initiatives and QA oversight of external manufacturing operations

Responsibilities

• Lead cross-functional collaboration with Manufacturing, Quality Control, MSAT and Regulatory Affairs to resolve deviations and ensure compliance.
• Represent Quality on cross-functional teams as a senior technical resource and decision-maker.
• Provide Quality oversight of change controls, investigations, CAPAs, and batch records for external drug substance disposition.
• Review regulatory submissions and support audits to ensure technical accuracy and regulatory alignment.

Skills

Leadership

Quality risk mgmt

Cross-functional collaboration

Decision making

Mentoring

Communication

Independent work

Education

Bachelor's degree in science or allied health

Tools

QDocs

TrackWise

Veeva

Job description

Vertex is seeking an Associate Director, GMP Operational Quality Assurance in Boston to lead day-to-day quality operations across complex programs. This role partners with Product Quality Leads, MSAT, Regulatory Affairs, and external CDMOs to ensure patient safety, product quality, and regulatory compliance.

The role requires extensive experience in cGMP biologics and the ability to mentor teams, analyze quality metrics, and drive CAPA and risk-based decisions.