Senior Manager, GMP QA Operations

Location: Onsite in Waltham, Massachusetts, United States

Salary: $160,000–$185,000 USD annually

Company

hirify.global develops 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

• Oversee Drug Substance and Drug Product release activities, including batch record review, disposition decisions, disposition packages, and Certificates of Conformance.
• Lead GMP QA interactions with contract manufacturing organizations through governance meetings and operational discussions.
• Monitor vendor quality performance and ensure manufacturing and testing activities meet regulatory and internal requirements.
• Lead deviation investigations, root cause analysis, CAPA development, tracking, and effectiveness verification.
• Support change management, batch record review, quality event management, and Quality Operations KPI reporting for Management Review.
• Collaborate with Manufacturing, Quality Control, Supply Chain, Regulatory Affairs, Project Management, and Quality Management Systems teams.

Requirements

• Bachelor’s degree in Engineering, Science, or a related discipline; a master’s degree is preferred.
• At least 6 years of experience in a cGMP environment and at least 4 years in Quality Assurance or a closely related role within a regulated industry.
• Experience overseeing CMO or CDMO organizations is preferred.
• Working knowledge of international regulations and guidance, especially FDA and EMA requirements.
• Experience with GxP QA systems and processes, including documentation and records management, change control, deviations, investigations, training, and CAPA.
• Strong judgment, organization, communication, presentation, problem-solving, and cross-functional collaboration skills.

Nice to have

• Experience in the therapeutic industry.
• Proficiency with SmartSheet, Veeva, and Microsoft Office.

Culture & Benefits

• Onsite work environment in Waltham, Massachusetts.
• Cross-functional collaboration across manufacturing, quality, supply chain, regulatory, and project management.
• Opportunity to improve GMP quality processes supporting clinical development and future commercialization.
• Equal opportunity employment practices.