Associate Director, GMP Quality Ops (Biologics/Devices) – Hybrid

Regulatory Jobs; Boston (MA); Hybrid; USD 95,000 - 142,000; Full time

Job summary

Vertex is seeking an Associate Director, GMP Operational Quality Assurance to provide Quality oversight across development through process performance qualification, ensuring patient safety and regulatory alignment. The role partners with Product Quality Leads, MSAT, Regulatory Affairs, CDMOs, and suppliers.

You will lead day-to-day quality operations, oversee deviations, CAPA investigations, change controls, and complex investigations, and guide external drug substance disposition and

Qualifications

• Bachelor's degree in a scientific or allied health field.
• 8+ years of GMP Quality experience with leadership of complex initiatives and QA oversight.
• Experience mentoring others and influencing cross-functional teams.

Responsibilities

• Lead cross-functional collaboration to resolve deviations and ensure compliance.
• Represent Quality on cross-functional teams as senior technical resource.
• Oversee Quality Agreements with CDMOs, suppliers, and Vertex.
• Provide Quality oversight to Change Control and risk-based decisions.
• Lead investigations and CAPA programs with robust root-cause analysis.
• Review batch records and regulatory submissions for accuracy.
• Drive quality metrics analysis and continuous improvement.

Skills

GMP knowledge

Leadership

Quality risk management

Cross-functional collaboration

Regulatory liaison

Investigations & CAPA

Education

Bachelor's degree in science or allied health

8+ years GMP Quality experience

Tools

QDocs

TrackWise

Veeva

Job description

Vertex is seeking an Associate Director, GMP Operational Quality Assurance to provide Quality oversight across development through process performance qualification, ensuring patient safety and regulatory alignment. The role partners with Product Quality Leads, MSAT, Regulatory Affairs, CDMOs, and suppliers.

You will lead day-to-day quality operations, oversee deviations, CAPA investigations, change controls, and complex investigations, and guide external drug substance disposition and