Senior Manager, Quality Control Operations

Position Summary

We are seeking a Senior Manager, Quality Control Operations to lead project and operational planning across the Quality Control (QC) organization within Rocket Pharmaceuticals gene therapy manufacturing facility in Cranbury, NJ. This individual will manage cross-functional QC initiatives from initiation through completion, translating priorities into integrated plans, schedules, resource requirements, risk assessments, and clear performance reporting. The role will coordinate internal teams and external testing partners, drive stakeholder alignment, and strengthen standardized project management and operational excellence practices across QC. The Senior Manager will also support laboratory compliance and inspection readiness, continuous improvement and CAPA activities, controlled Quality documentation, QC operational workflows, and departmental budget and vendor management. The successful candidate will bring demonstrated experience in Quality Control within GxP-regulated biopharmaceutical manufacturing, strong project and stakeholder management capabilities, and the ability to navigate competing priorities while driving measurable results.

Responsibilities

• Lead quality-focused projects from initiation through completion, partnering cross-functionally with Technical Development, Regulatory, Manufacturing, Clinical, Supply Chain, and other key stakeholders.
• Develop and maintain comprehensive project plans, schedules, resource requirements, priorities, dependencies, dashboards, status reports, meeting minutes, and issue/risk logs.
• Leverage data and project insights to inform prioritization, resource allocation, project acceleration, redesign, and other key project decisions.
• Establish and implement standardized project management and operational excellence methodologies, tools, and best practices to drive consistency and organizational effectiveness.
• Build and facilitate cross-functional project teams, fostering effective communication, stakeholder alignment, collaborative problem-solving, and timely execution of project objectives.
• Coordinate and oversee contracted laboratory services and external testing partners, including scheduling, deliverables, timelines, and issue resolution.
• Facilitate QC project and operational meetings and ensure clear, timely communication of priorities, risks, decisions, and deliverables across internal and external stakeholders.
• Author and review, as appropriate, SOPs, policies, protocols, technical reports, and other controlled Quality documentation.
• Provide training, coaching, and mentorship to QC analytical staff on project management, operational excellence, and applicable Quality processes.
• Oversee QC operational activities, including inventory management, sample movement, and coordination with Supply Chain and other cross-functional partners.
• Conduct stakeholder feedback sessions, process mapping, and business process analyses to identify opportunities for increased efficiency, effectiveness, and standardization.
• Lead continuous improvement initiatives and support the development and implementation of corrective and preventive actions (CAPAs) across Quality and QC functions.
• Manage and support QC investigations, deviations, change controls, and CAPAs, ensuring appropriate documentation, timely resolution, and effective implementation.
• Support QC laboratory compliance, documentation integrity, inspection readiness, and adherence to applicable cGMP regulations, FDA/ICH guidelines, and Quality System requirements.
• Support Quality Agreements, regulatory filings, and Health Authority activities, as applicable.
• Partner with Quality leadership and Finance on annual budget planning, forecasting, and ongoing management of departmental spending and resources.

Qualifications

• With a Master’s Degree: 5 years of experience in a Quality Control laboratory within GxP-regulated biopharmaceutical manufacturing operations.
• With a Bachelor’s Degree: 8 years of experience in a Quality Control laboratory within GxP-regulated biopharmaceutical manufacturing operations.
• Experienced in QC capacity management across contract testing laboratories (CTLs), including prioritization of testing, constraint identification, and strategic resource coordination.
• Advanced proficiency with Smartsheet and Microsoft tools (Excel, PowerPoint, Teams, SharePoint, Project) and established project management methodologies.
• Proficiency with Laboratory Information Management Systems (LIMS) and experience with Laboratory Execution Systems (LES) and Electronic Laboratory Notebooks (ELN) are preferred.
• Drive results by setting clear outcomes, tracking progress, following through on commitments, and taking accountability for measurable results that advance organizational objectives.