Director, Analytical Product Quality (Biotech)

TL;DR

Director, Analytical Product Quality (Biotech): Providing quality oversight for analytical development activities throughout the product lifecycle for Cell & Genetic therapy programs with an accent on method validation and regulatory compliance. Focus on driving investigations for out-of-specification results, managing reference standard programs, and ensuring adherence to FDA and EMA standards.

Location: On-site in Boston, MA

Salary: $180,800 - $271,200

Company

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

What you will do

• Maintain Quality Assurance oversight of method development and qualification activities.
• Manage the stability program to ensure compliance with internal procedures and EU/US regulatory standards.
• Lead quality reviews for analytical method validation protocols and reports.
• Drive investigations for out-of-specifications, root cause analysis, and CAPA implementation.
• Oversee the reference standard program and manage contract test labs including Quality Agreements.
• Support regulatory submissions (INDs) and respond to agency questions.

Requirements

• Bachelor's, Master's, or PhD in engineering or Lifesciences.
• 10+ years of industry experience in manufacturing, QA, or QC within a biotechnology or regulated pharmaceutical environment.
• In-depth knowledge of GXP, ICH Guidelines, and FDA/EMA regulations for Cell & Gene therapy and Biologics.
• Experience in method development for cellular programs and clinical product development.
• Proficiency in Root Cause Analysis and Operational Excellence (LEAN, DMAIC, Six Sigma).
• Must be based in or work on-site in Boston, MA.

Culture & Benefits

• Inclusive market-leading medical, dental, and vision benefits.
• Generous paid time off, including company-wide shutdowns in Summer and Winter.
• Financial support including 401(k) and student loan repayment assistance.
• Educational assistance programs and commuting subsidies.
• Commitment to equal employment opportunity and a culture of scientific excellence.