Director CMC Quality Compliance (Biotech)

Location: Boston, MA, United States. Hybrid work allows remote work up to two days per week, or an on-site schedule five days per week with ad hoc flexibility. Travel of 5–10% may be required.

Salary: $184,600–$277,000 base salary annually, plus annual bonus and equity eligibility.

Company

Vertex is a global biotechnology company focused on scientific innovation and the development of medicines.

What you will do

• Lead inspection readiness, inspection management, and compliance programs across GMP areas.
• Oversee compliance at internal manufacturing and testing sites and external contract manufacturing organizations.
• Monitor cGMP regulations and regulatory trends, incorporating them into phase-appropriate control strategies.
• Identify compliance risks, implement improvement plans, and strengthen quality culture across sites.
• Maintain the inspection readiness and management system, including escalations and leadership reporting.
• Provide strategic leadership, coaching, and development for staff while supporting the integration of new modalities into quality systems.

Requirements

• Bachelor’s degree in a scientific or allied health field, or equivalent education.
• Typically 10 years of relevant work experience and 3 years of management experience, or an equivalent combination.
• Expert knowledge of global GMP requirements and experience across multiple GxP areas.
• Strong technical knowledge of GMP regulations, inspection management, risk management, and quality governance.
• Proven ability to lead teams, facilitate collaboration, communicate effectively, and coach or influence stakeholders.
• Ability to evaluate quality matters and make risk-based decisions.

Culture & Benefits

• Continuous learning and support for staying current with AI, technology, automation, and industry trends.
• Medical, dental, and vision benefits.
• Generous paid time off, including summer and winter company shutdowns.
• Educational assistance, student loan repayment, commuting subsidy, charitable donation matching, and 401(k).
• Annual bonus and equity award eligibility.