Associate Director, Quality Systems

Legend Biotech is seeking an Associate Director, Quality Systems as part of the Quality team based in Raritan, NJ. 

Role Overview

The Associate Director, Quality Systems is a member of the Raritan Quality Leadership Team with responsibilities for quality systems oversight within a cell therapy manufacturing plant to support commercial requirements in a sterile GMP environment. This role will oversee a team of quality systems specialists responsible for managing systems and associated processes and procedures, including document control, investigations, CAPA, change control, site quality metrics, and laboratory QA oversight. They will also support site quality compliance, including site inspection readiness and support during regulatory inspections.

Key Responsibilities

• Provide quality systems oversight for the CAR-T manufacturing site
• Responsible for oversight of Quality Systems, Systems Support, and Investigations teams to meet goals and deadlines.
• Ability to manage multiple and complex projects, provide status reports, and coordinate with other departments
• Manage cross-functional projects with many stakeholders and collaborate with functional departments to resolve issues.
• Require minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consult with supervisor for decisions outside established processes.
• Identify efficiencies within the teams to enhance compliance and improve productivity.
• Lead the implementation and continuous improvement of Quality Risk Management (QRM) processes in accordance with applicable regulatory requirements and site procedures
• Facilitate cross-functional risk assessments (e.g., FMEA, hazard analysis, impact assessments) to identify, evaluate, and mitigate quality, compliance, and operational risks.
• Ensure risks associated with investigations, deviations, CAPAs, changes, and process improvements are appropriately assessed, documented, and monitored through closure.
• Monitor quality trends, recurring events, backlog metrics, and emerging signals to proactively identify systemic risks and recommend preventive actions.
• Partner with Manufacturing, Quality Control, Engineering, Supply Chain, and Technical Operations to harmonize procedures, processes and systems, and drive risk-based decision making across site operations.
• Present key quality and compliance risks, mitigation strategies, and risk trends to site leadership and governance forums.
• Evaluate the effectiveness of risk controls and CAPAs to ensure sustainable risk reduction and prevention of recurrence.
• Drive a proactive risk culture by coaching investigators, quality leads, and cross-functional teams on risk identification, assessment methodologies, and mitigation strategies.
• Utilize quality metrics and analytics to identify high-risk processes, recurring failure modes, and opportunities for continuous improvement.
• Lead and provide expert guidance for complex, high-risk, critical, and OOS investigations; facilitate investigation strategy meetings and root cause analysis workshops.
• Review and approve highly complex investigations, CAPAs, corrections, and effectiveness checks to support robust root cause determination and sustainable corrective actions.
• Monitor, trend, and report investigation and CAPA quality, timeliness, backlog, aging, recurrence, and effectiveness metrics; develop dashboards, KPIs, and performance management tools
• Lead investigation excellence initiatives focused on investigation quality, cycle time, root cause effectiveness, inspection readiness, and site-wide accountability.
• Lead governance forums, including Quality Lead meetings, CAPA Forum, and investigation coaching and mentoring sessions.
• Provide guidance to other employees in the interpretation of quality issues
• Develop project charters, timelines, resource plans, risk assessments, and success metrics; lead cross-functional teams through implementation and sustainment.
• Support improvements to procedures, standards, training qualification, coaching, and governance processes; lead maturity assessments and benchmarking activities.
• Manage strategic and continuous improvement projects supporting process optimization, CAPA effectiveness, digitalization, compliance enhancement, and quality risk management integration.
• Act as the Investigation Governance SME during audits and regulatory inspections; present program metrics and governance activities and drive sustainable responses to observations.
• Support regulatory inspections and audits by serving as a subject matter expert for Quality Systems.
• Support Global Quality and Site Compliance Team by conducting periodic reviews of site compliance, inspection readiness, and quality system health to identify and mitigate emerging compliance risks
• Perform responsibilities in accordance with safety policies, quality systems, and cGMP requirements; complete other duties as assigned.
• Works collaboratively with Quality Control, Manufacturing Operations, Technical Operations, Engineering and Maintenance, Supply Chain and Planning, Quality Assurance, Validation, Quality Compliance, above-site stakeholders, business units, and other functional investigation leaders.

Requirements

• Bachelor’s degree in Science, Engineering, Biotechnology, Pharmacy, Information Science, Biology, or a related technical discipline is required. An advanced degree is preferred.
• Minimum 10 years of Quality experience within a cGMP-regulated manufacturing facility, biotechnology, biopharmaceutical, or Cell & Gene Therapy manufacturing environment. Sterile manufacturing experience preferred. Demonstrated experience leading quality systems, complex investigations, CAPA programs, governance programs, quality improvement initiatives, cross-functional projects, and regulatory inspection or audit readiness activities is required.

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