Associate Director, Global GxP Governance, Risk & Intelligence (Pharma)

TL;DR

Associate Director, Global GxP Governance, Risk & Intelligence (Pharma): Leading global quality governance, risk management, and knowledge management programs to strengthen proactive quality oversight with an accent on the integration of risk intelligence and data insights. Focus on implementing Quality Risk Management (ICH Q9) and the Pharmaceutical Quality System (ICH Q10) across GMP, GCP, GLP, GVP, and GDP-regulated activities.

Location: Hybrid (Boston, MA)

Company

Vertex is a global biotechnology company that invests in scientific innovation to treat serious diseases.

What you will do

• Design, implement, and maintain an integrated Global Quality Governance Model across GxP domains.
• Manage and maintain the Global Quality Risk Management (QRM) framework in compliance with ICH Q9 and ICH Q10.
• Oversee the Global Quality Knowledge Management framework to ensure systematic capture and accessibility of critical quality insights.
• Analyze quality data trends and establish signal detection mechanisms to identify emerging systemic risks.
• Provide risk intelligence and governance support to Quality Leadership and senior executive forums.
• Drive a proactive, risk-based culture of quality across various product modalities and geographies.

Requirements

• Must be based in or be able to work in Boston, MA (Hybrid eligibility).
• M.S. with 8+ years of relevant experience, or B.S. in a scientific field with 10+ years of experience.
• Deep expertise in Quality Risk Management (QRM) and ICH Q9/Q10 standards within a Pharmaceutical Quality System.
• Proven experience designing and governing risk frameworks across multiple GxP domains (GMP, GCP, GLP, GVP, GDP).
• Strong ability to translate complex quality data into actionable risk intelligence and strategic insights.
• Experience serving as a Global Process Owner or enterprise lead for critical quality systems.

Nice to have

• Professional certification in Lean Six Sigma, RAPS, SQA, ASQ, or DIA.
• Experience with structured problem-solving methodologies such as Root Cause Analysis or DMAIC.

Culture & Benefits

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