Director CMC Quality Compliance (Biotech)

TL;DR

Director CMC Quality Compliance (Biotech): Leading inspection readiness and GMP compliance for internal and external manufacturing sites with an accent on risk-based quality culture and governance. Focus on overseeing CMOs, monitoring regulatory trends, and implementing scalable quality systems for new modalities.

Location: Boston, MA. Hybrid-eligible (up to 2 days remote) or On-site.

Salary: $184,600 - $277,000

Company

Global biotechnology company that invests in scientific innovation.

What you will do

• Lead inspection readiness and compliance programs across all GMP areas, including external CMOs and internal sites.
• Monitor and integrate cGMP regulatory guidelines into phase-appropriate control strategies.
• Identify compliance risks and implement action plans to improve the overall quality culture.
• Report on the health of the inspection management system and ensure appropriate escalations to leadership.
• Scale inspection programs to integrate new modalities as the company expands its scope of operations.
• Provide strategic leadership, development, and coaching to staff as a people manager.

Requirements

• Bachelor's degree in a scientific or allied health field.
• 10+ years of work experience and 3+ years of management experience.
• Expert knowledge of global GMP requirements and experience across multiple GxP areas.
• Proven ability to evaluate quality matters and make decisions using a risk-based approach.
• Strong technical knowledge in inspection management, risk management, and quality governance.
• Must be based in the Boston, MA area to support hybrid or on-site work.

Culture & Benefits

• Comprehensive medical, dental, and vision benefits.
• Generous paid time off, including company-wide summer and winter shutdowns.
• Financial perks including 401(k), annual bonus, and annual equity awards.
• Commuting subsidy and educational assistance programs, including student loan repayment.
• Flexible work options with hybrid-eligible designations.