Associate Director, GMP QA Operations (Biotech)

Location: Waltham, MA; onsite

Salary: $175,000–$200,000 USD base pay

Company

Biotechnology company developing therapeutics targeting muscle and the central nervous system for genetically driven neuromuscular diseases, including Duchenne muscular dystrophy and myotonic dystrophy type 1.

What you will do

• Lead QA oversight for external manufacturing and testing teams, CMOs, CDMOs, and other external partners.
• Oversee GMP release activities for drug substance intermediates, drug substance, and drug product, including batch record review and disposition decisions.
• Lead or support investigations, root cause analysis, CAPA development, change management, and effectiveness verification.
• Develop and maintain quality systems, procedures, policies, documentation, records, and quality operations metrics.
• Support domestic and international CMO audits, internal audits, regulatory submissions, and inspection readiness.
• Partner with CMC, Regulatory Affairs, and Project Management while communicating quality risks and mentoring QA team members.

Requirements

• Bachelor’s degree in Engineering, Science, or a relevant discipline; a master’s degree is preferred.
• 8+ years of experience in a cGMP environment and 5+ years in Quality Assurance or a closely related role within a regulated industry.
• Experience overseeing CMO or CDMO organizations is preferred.
• Understanding of international regulations and guidance, particularly FDA and EMA requirements.
• Experience with GxP QA systems and processes, including documentation and record management, change control, deviations, investigations, training, and CAPA.
• Strong judgment, organization, communication, presentation, collaboration, and problem-solving skills.

Nice to have

• Working knowledge of the therapeutic industry.
• Proficiency with SmartSheet and Veeva; experience with Microsoft Office applications.

Culture & Benefits

• Work onsite in Waltham, Massachusetts.
• Collaborative environment involving CMC, Regulatory Affairs, Project Management, CMOs, and external testing partners.
• Opportunity to contribute to quality strategy, continuous improvement, and development of therapies for neuromuscular diseases.
• Equal opportunity employment environment.