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

Location: Boston, MA, United States. Hybrid work is available remotely up to two days per week, or candidates may choose on-site work five days per week. International travel of up to 10–20% may be required.

Salary: $147,500–$221,300 base salary per year, plus eligibility for an annual bonus and annual 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.
• Evaluate, improve, and monitor commercial-level quality compliance and quality culture at external sites.
• Identify and resolve compliance issues, gaps, and risks through assessments, audits, operational collaboration, and trend evaluation.
• Support and oversee inspection execution, including responses and CAPA closure.
• Integrate multiple functions, build partnerships with external sites, and facilitate knowledge sharing.
• Report inspection readiness status and risks to leadership and governance forums while driving continuous improvement and operational excellence.

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 knowledge of inspection management and risk management.
• Experience leading improvement projects, project teams, cross-functional forums, and organizational collaboration.
• Strong facilitation, communication, coaching, influencing, and performance-indicator analysis skills.

Nice to have

• Experience working across multiple modalities.
• Continuous improvement experience involving Six Sigma or Lean.

Culture & Benefits

• Continuous learning and exposure to 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).