GCP Quality Associate Director (Biotech)

TL;DR

GCP Quality Associate Director (Biotech): Managing quality assurance and compliance activities for GCP related events within RDQ with an accent on issue management and escalation to senior management. Focus on conducting root cause analysis, implementing CAPAs, and ensuring inspection readiness.

Location: Boston, MA (Hybrid or On-Site)

Salary: $160,600 - $240,800

Company

Vertex is a global biotechnology company that invests in scientific innovation.

What you will do

• Manage GCP Quality Events including investigations, CAPAs, and Root Cause Analysis.
• Perform initial triage of event criticality and escalate major findings to management.
• Develop and monitor KPIs, dashboards, and reports to inform continuous improvement.
• Serve as a Subject Matter Expert for risk-based quality event approaches.
• Support inspection readiness and audit activities.
• Assist with onboarding and training team members.

Requirements

• Bachelor’s Degree and 10 years of relevant work experience.
• Proven experience leading event investigations, Root Cause Analysis, and CAPA.
• Strong knowledge of GCP quality management and current industry trends.
• Experience with Health Authority inspections and audits.
• Strong communication and critical thinking skills.
• Must be based in or able to work from Boston, MA.

Culture & Benefits

• Comprehensive health insurance including medical, dental, and vision.
• Annual bonus and annual equity awards.
• Generous paid time off, including company-wide shutdowns in Summer and Winter.
• 401(k) and commuting subsidy.
• Educational assistance programs and student loan repayment.