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 deviations, CAPAs, and complaints
• Ensure timely lot disposition and deviation closure
• Report quality system metrics, lead CAPA investigations, and drive continuous improvement initiatives
• Foster and develop intra- and inter-departmental relationships including collaboration with global teams to implement best practices
• Support internal and external audits, including preparation of audit reports and responses
• Participate in developing project plans
• Evaluate and mitigate program risk and escalate quality issues as needed
• Provide Quality Assurance input and oversight for clinical and commercial projects, including technical transfers and the stability program
• Support internal audits, customer audits, and regulatory inspections
• Support Quality Management Reviews
• Partner with site leadership and global Quality teams to align local quality systems with corporate and regulatory expectations
Supervisory Responsibilities
• Recruit, hire, coach, and train employees within the QA operations group.
• Identify gaps and ensure the proper hiring and development of employees with the support of Human Resources.
• Set clear performance expectations, provide regular feedback and coaching, and manage performance in alignment with company objectives.
Education / Experience
• B.S. degree in science or a life science-related field of study
• 7+ years of experience in Quality Assurance in a GMP-regulated environment
• Minimum of 3 years of people management experience, including direct report leadership
• Strong knowledge of FDA, ICH, and EU GxP Regulations and Guidelines
• Experience with ensuring alignment with relevant guidance and regulations
• Experience with root cause analysis, CAPA and internal audit systems
• Experience working with Risk Management and New Product Development
• Management of major and critical investigations, complaints, and CAPAs
• Involvement in continuous improvement initiatives
• Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO) experience preferred
• Proficiency in Microsoft Office suite applications
• Experience working with electronic quality management systems (eQMS) and document control systems
This position is fully on-site and requires five days per week at our Watertown, MA location.
Annual base salary range: $135,000 - $175,000