Associate Director, CMC Quality Compliance and Inspection Readiness (Hybrid)

Location: Boston, Massachusetts, United States. Hybrid option with remote work up to two days per week, or on-site work five days per week with ad hoc flexibility. International travel of up to 10–20% may be required.

Salary: $147,500–$221,300 base salary per year, plus potential annual bonus and equity awards.

Company

Vertex is a global biotechnology company focused on scientific innovation and developing better outcomes for patients.

What you will do

• Lead inspection readiness and quality compliance programs for external operations and sites.
• Evaluate, improve, and monitor commercial-level quality compliance and quality culture.
• Identify and resolve issues, compliance gaps, and risks through assessments, audits, collaboration, and trend analysis.
• Support and oversee inspection execution, including responses and CAPA closure.
• Coordinate cross-functional teams, external sites, knowledge-sharing forums, and improvement projects.
• Report inspection readiness status and risks to leadership and governance forums.

Requirements

• Bachelor’s degree in a scientific discipline, allied health field, or equivalent.
• 8+ years of relevant experience.
• Knowledge of global regulatory requirements and inspection expectations.
• Technical expertise in inspection management and risk management.
• Proven ability to lead improvement projects, project teams, and cross-functional forums.
• Strong facilitation, communication, coaching, influencing, and performance-indicator analysis skills.

Nice to have

• Experience across multiple modalities.
• Continuous improvement experience using Six Sigma or Lean methodologies.

Culture & Benefits

• Continuous learning focused on advances in AI, technology, automation, and industry trends.
• Medical, dental, and vision benefits.
• Generous paid time off, including summer and winter company shutdowns.
• Educational assistance programs, including student loan repayment.
• Commuting subsidy, matching charitable donations, and 401(k).