Senior GMP Quality Lead - Biologics & Devices

Vertex Pharmaceuticals LLC; Boston (MA); Hybrid; USD 95,000 - 142,000; Full time

Job summary

Vertex Pharmaceuticals is seeking an Associate Director, GMP Operational Quality Assurance in Boston to provide strategic quality leadership across external manufacturing and internal teams. You will guide deviation investigations, CAPA plans, and change controls to safeguard patient safety and product quality.

You will interact with Product Quality Leads, MSAT, Regulatory Affairs, CDMOs, and suppliers, lead quality risk assessments, review batch records, and support audits and regulatory

Qualifications

• Bachelor's degree in a scientific field required.
• 8+ years of GMP Quality experience, including external manufacturing oversight.
• Experience leading investigations, CAPA, and change controls.
• Strong problem-solving, communication, and stakeholder management.

Responsibilities

• Lead cross-functional quality operations and resolve deviations.
• Draft and oversee Quality Agreements with CDMOs and suppliers.
• Provide QA direction for change controls and CAPA implementation.
• Review batch records and investigations for drug substance disposition.
• Identify and mitigate quality risks across programs.
• Prepare for regulatory audits and submissions.
• Drive quality readiness for IND/IMPD milestones.

Skills

Quality leadership

Problem solving

Communication

Mentoring

Independent judgment

Education

Bachelor's degree in science

Tools

QDocs

TrackWise

Veeva

Job description

Vertex Pharmaceuticals is seeking an Associate Director, GMP Operational Quality Assurance in Boston to provide strategic quality leadership across external manufacturing and internal teams. You will guide deviation investigations, CAPA plans, and change controls to safeguard patient safety and product quality.

You will interact with Product Quality Leads, MSAT, Regulatory Affairs, CDMOs, and suppliers, lead quality risk assessments, review batch records, and support audits and regulatory