Associate Director, GMP Quality - Biologics & Devices

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

Job summary

Vertex is seeking an Associate Director, GMP Operational Quality Assurance to lead day-to-day quality operations across multiple programs, ensuring decisions align with patient safety, product quality, regulatory expectations, and business continuity.

This role partners with Product Quality Leads, MSAT, Regulatory Affairs, and CDMOs, driving risk management, CAPA, deviations investigations, and quality oversight for external drug substance dispositions across development through process

Qualifications

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

Responsibilities

• Lead cross-functional collaboration to resolve deviations and ensure patient safety and regulatory compliance.
• Represent Quality on cross-functional teams as senior technical resource/decision-maker.
• Provide Quality leadership for deviation investigations, CAPA, and change controls.
• Review and approve master/ executed batch records for external drug substance disposition.
• Drive Quality readiness for major development milestones including IND/IMPD submissions and regulatory inspections.

Skills

cGMP knowledge

Biologics

Leadership

Quality risk management

QA oversight

Regulatory compliance

Audits

Cross-functional collaboration

Root cause analysis

Education

Bachelor’s degree in a scientific or allied health field

Tools

QDocs

TrackWise

Veeva

Job description

Vertex is seeking an Associate Director, GMP Operational Quality Assurance to lead day-to-day quality operations across multiple programs, ensuring decisions align with patient safety, product quality, regulatory expectations, and business continuity.

This role partners with Product Quality Leads, MSAT, Regulatory Affairs, and CDMOs, driving risk management, CAPA, deviations investigations, and quality oversight for external drug substance dispositions across development through process