Associate Director, Quality Systems

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.
• Able 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.
• 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.
• Perform responsibilities in accordance with safety policies, quality systems, and cGMP requirements; complete other duties as assigned.

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.