Senior Manager, Quality Control Operations

About the role

Rocket Pharma is a fully integrated, late‑stage biotechnology company advancing gene therapies with curative potential for patients with rare and life‑threatening diseases. The company values a collaborative environment where bold ideas thrive, guided by core values of trust, generosity toward patients, curiosity, and elevating science.

Position Summary

The Senior Manager, Quality Control Operations will lead project and operational planning across the Quality Control (QC) organization within Rocket Pharmaceuticals’ gene therapy manufacturing facility in Cranbury, NJ. This role manages cross‑functional QC initiatives from initiation through completion, translating priorities into integrated plans, schedules, resource requirements, risk assessments, and clear performance reporting. Responsibilities also include supporting laboratory compliance, inspection readiness, continuous improvement, CAPA activities, controlled Quality documentation, QC operational workflows, and departmental budget and vendor management.

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.
• Experience 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); experience with Laboratory Execution Systems (LES) and Electronic Laboratory Notebooks (ELN) is preferred.
• Demonstrated ability to drive results by setting clear outcomes, tracking progress, following through on commitments, and taking accountability for measurable outcomes that advance organizational objectives.

Compensation

The expected salary range for this position is $118,000 to $158,000. Compensation is based on responsibilities, experience, location, and market factors, and may be adjusted at hire or during the year.

Benefits

• Competitive total rewards package, including potential bonuses (short‑term incentives).
• Medical, dental, and vision insurance.
• Life insurance.
• 401(k) plan with company match and generous vesting.
• Paid vacation and holidays, plus global shutdown days between Christmas and New Year’s.
• Wellness resources and employee support programs.
• Eligibility for equity awards (long‑term incentives) where applicable.