Senior Manager, Manufacturing Technical Services

Job Description

General

Summary:

The Senior Manager, Manufacturing Technical Operations (MTO), is responsible for developing and executing the quality-record strategy for quality events supporting internal Cell and Gene Therapy (CGT) manufacturing. The role provides end-to-end oversight of quality events, including corrective and preventive actions (CAPAs), change controls, deviations, and analytical investigations.

Responsibilities include reviewing quality metrics and trends; escalating cross-functional risks and issues; and establishing operational excellence practices that strengthen quality event compliance, investigation quality, timely record closure, and the sustainable implementation of CAPAs and change controls. The Senior Manager partners closely with Manufacturing, Quality Assurance, and other cross-functional stakeholders to promote a quality event center of excellence and support continuous improvement across the site.

This is an on-site position at the Boston site that requires 2nd shift/weekend availability to support manufacturing business needs.

• Lead and develop a high-performing team of five or more responsible for quality-record execution, including change controls, CAPAs, deviations, and analytical investigations
• Provide strategic oversight and project leadership for complex, high-impact CAPA and change-control records
• Lead cross-functional investigations for major and critical deviations to determine root cause, define appropriate corrective and preventive actions, and present findings and recommendations to the leadership team for endorsement
• Establish, implement, and continuously promote MTO- and QA-aligned best practices to advance quality-event center-of-excellence capabilities
• Lead triage and proposal meetings for deviations, analytical investigations, CAPAs, and change controls
• Monitor quality-event performance, including compliance metrics, record-aging data, and recurring trends, to identify risks, prioritize work, and allocate resources using data-driven decisions
• Drive continuous improvement of departmental and site practices, procedures, systems, and activities related to quality-event management.
• Partner with cross-functional stakeholders to ensure timely, compliant, and effective closure of quality records
• Support inspection readiness by ensuring quality-event documentation is complete, scientifically sound, and aligned with applicable GMP requirements
• Perform other duties and lead additional projects as needed to meet departmental and business requirements

• In-depth knowledge of the conceptual and practical application of current Good Manufacturing Practices (cGMPs) within a pharmaceutical or biopharmaceutical manufacturing environment
• Strong understanding of global GMP requirements and quality-system expectations supporting GMP manufacturing
• Demonstrated experience managing complex projects, priorities, timelines, and cross-functional stakeholders
• Strong analytical and problem-solving skills, including the ability to evaluate trends, identify systemic issues, and implement sustainable improvements
• Excellent verbal and written communication skills, with the ability to tailor messaging, terminology, and level of detail to the intended audience
• Strong leadership skills and a demonstrated ability to collaborate, influence, and build productive relationships across functions
• Excellent planning, prioritization, and organizational skills, with the ability to balance production, development, compliance, and continuous-improvement needs

• Bachelor’s degree in engineering, Life Sciences, or a related technical discipline; equivalent combinations of education and relevant experience may be considered
• 6+…