Quality Product Complaints Associate Director (Biotech)

TL;DR

Quality Product Complaints Associate Director (Biotech): Providing quality oversight of the Product Complaint Quality System and Global Recall systems with an accent on regulatory compliance, root cause analysis, and risk management. Focus on driving continuous improvement through automation and AI-driven solutions to ensure adherence to GMP and GDP standards.

Location: Must be based in Boston, MA (Hybrid-Eligible: remote up to 2 days per week or On-Site)

Company

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

What you will do

• Own the end-to-end complaints process, including handling, capability identification, and implementation of improvements.
• Lead complex, high-risk product complaint investigations, performing Root Cause Analysis and identifying Corrective Actions (CAPA).
• Manage global recall and defect notification processes, including mock recalls and SOP maintenance.
• Identify and implement automation and AI-driven solutions to enhance operational efficiency and compliance robustness.
• Partner with cross-functional teams including Global Patient Safety, Supply Chain, Quality Assurance, and CMOs.
• Develop risk thresholds and triggers to proactively identify issues before they become reportable events.

Requirements

• Must be based in or able to work from Boston, MA.
• Master's degree with 5-8 years of relevant experience, or Bachelor's degree with 10+ years of experience in a scientific or allied health field.
• Expert knowledge of GMP and GDP, including US and international regulatory requirements across multiple modalities.
• Proven experience in Product Complaints, Recalls, Field Alerts, and Defect Notifications to Health Authorities.
• Strong proficiency in Risk Management, Event/Quality Issue Management, and CAPA processes.
• Exceptional technical writing, analytical thinking, and communication skills.

Culture & Benefits

• Comprehensive medical, dental, and vision benefits.
• Generous paid time off, including company-wide shutdowns in Summer and Winter.
• Financial perks including 401(k), student loan repayment, and a commuting subsidy.
• Educational assistance programs to support professional growth.
• Commitment to equal employment opportunity and a non-discriminatory work environment.