Manager, Quality Assurance Operations

Manager, Quality Assurance Operations
Watertown, Massachusetts

About the job
The Quality Assurance Operations Manager is responsible for leading and overseeing late phase and commercial quality operations activities. This role promotes a strong culture of compliance through proactive quality oversight of process and material life cycles and plays a key role in building scalable quality systems and driving cross-functional collaboration.

Essential Duties And Responsibilities
• Hire, develop, and train department personnel to support Quality Assurance Operations responsibilities and career growth
• Actively participate in fostering a positive, collaborative work culture
• Ensure adherence to cGMPs across the organization
• Manage incoming material release, product batch record review, lot disposition, review of process validation protocols and reports
• Manage the deviation program and lead investigations, including deviat...