Manager, Internal Quality Operations

ModernaTX • Norwood, MA

3d • Onsite

About The Position

ModernaTX, Inc. seeks a Manager, Internal Quality Operations for its Norwood, Massachusetts location. This role involves overseeing Quality Assurance (QA) operations for clinical-stage drug product manufacturing, including isolator-based aseptic fill-finish and packaging and labeling processes, ensuring compliance with good manufacturing practices (GMP). The position serves as the QA contact for the development and startup of a new aseptic fill-finish manufacturing facility, supporting equipment qualification, process validation readiness, and the implementation of quality systems. The role provides QA operations support for drug product manufacturing, including aseptic behavior monitoring and oversight, batch record review, line clearance, visual inspection quality oversight, in-process checks, packaging and labeling review, and management of room changeovers. It also involves leading and coordinating deviation investigations and change controls for drug product manufacturing, driving documentation improvements by managing updates to batch records and standard operating procedures, and facilitating technology transfer scheduling and execution. Additionally, the role supports team development through mentoring, coaching, and performance feedback, contributes to hiring activities, promotes continuous improvement within the QA group, leads quality-driven projects, and contributes to quality oversight through review and presentation of performance metrics, risk summaries, and investigation status. The position also supports audit readiness for internal inspections and third-party audits and provides on-site support during audits.

Requirements

• Minimum of a Master’s degree in Biotechnology, Pharmaceutical Sciences, or related field and two (2) years of experience as a QA Specialist, Quality Control Specialist, Senior Technician – Quality Control, Sterility Assurance Specialist, or related position supporting Quality activities in healthcare manufacturing.
• Alternatively, a Bachelor’s degree in fields specified and five (5) years of the specified progressive, post-baccalaureate experience.
• Two (2) years of experience must include: GMP compliance and audit readiness and participation; Quality event management, including deviation investigations, and CAPA (Corrective and Preventive Actions); Quality data analysis to drive continuous improvement; and Quality system and documentation management utilizing eQMS (Electronic Quality Management System), EAM (Enterprise Asset Management), ERP (Enterprise Resource Planning) and MES (Manufacturing Execution System) platforms.
• Experience with providing QA support and quality support for facility-startup validation activities.

Responsibilities

• Oversee Quality Assurance (QA) operations for clinical-stage drug product manufacturing, including isolator-based aseptic fill-finish and packaging and labeling processes, ensuring compliance with good manufacturing practices (GMP).
• Serve as the QA contact for the development and startup of a new aseptic fill-finish manufacturing facility, supporting equipment qualification, process validation readiness, and implementation of quality systems.
• Provide QA operations support for drug product manufacturing, including aseptic behavior monitoring and oversight, batch record review, line clearance, visual inspection quality oversight, in-process checks, packaging and labeling review, and management of room changeovers.
• Lead and coordinate deviation investigations and change controls for drug product manufacturing, including coordination of root cause analysis, cross-functional impact assessments, and timely closure of major and recurring quality issues.
• Drive documentation improvements by managing updates to batch records and standard operating procedures to support manufacturing accuracy and regulatory compliance.
• Facilitate technology transfer scheduling and execution by coordinating with supply chain, engineering, manufacturing science and technology (MST) and manufacturing operations teams to align quality oversight with production planning, material traceability, and process control strategies.
• Support team development through mentoring, coaching, and performance feedback, while contributing to hiring activities and promoting continuous improvement within the QA group.
• Lead quality-driven projects to improve operational efficiency and compliance.
• Contribute to quality oversight through review and presentation of performance metrics, risk summaries, and investigation status to support proactive compliance and continuous improvement.
• Support audit readiness for internal inspections and third-party audits by ensuring documentation completeness, floor compliance, and cross-functional coordination.
• Provide on-site support during audits and serve as the drug product Quality point of contact.
• Oversee day-to-day quality assurance support services coordination including task delegation.

Benefits

• Best-in-class healthcare coverage
• Voluntary benefit programs
• Fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities
• Location-specific perks and extras
• Annual discretionary bonus, other incentive compensation, or equity award (subject to eligibility and performance)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager