Associate Director, Quality Systems

• Own the strategy, design and continuous improvement of the Quality Management System, ensuring it is phase-appropriate, scalable and aligned with company growth from early clinical through late-stage development. 

• Establish and maintain the quality manual, quality policies and the governing procedure hierarchy. 

• Serve as the process owner for core quality systems including 

• Documentation Management 

• Training 

• Deviations, CAPA, Effectiveness Checks 

• Change Control 

• Supplier Quality and Change Management 

• Quality Risk Management 

• Audit Management, including Supplier, Client and Internal   

• Implement a quality risk management program consistent with ICH Q9(R1), and embed risk-based decision making across Quality and operational functions. 

• Ensure compliance with applicable regulations and guidance documents 

• Lead the company’s supplier, client and internal audit readiness program 

• Support front-room or back-room audits, oversee timely and high-quality audit responses 

• Own the internal audit program, including annual audit planning, execution, reporting and CAPA follow-up 

• Oversee supplier qualification and monitoring program, including risk-based supplier audits and performance management 

• Define, trend and report key quality metrics and indicators to identify systemic risks and improvement opportunities 

• Lead the quality management review process and escalate significant compliance risks to senior leadership 

• Build, lead and develop high-performing Quality Systems team, including recruiting, setting performance objectives, coaching and planning career development discussions 

• Manage and own the Change Control Review Board 

• Partner with internal cross-functional stakeholders to foster a strong Culture of Quality, promoting shared accountability for compliance and right-first-time performance 

• Influence internal cross-functional stakeholders to drive timely closure of quality records 

Education 

• Minimum Bachelor’s degree is STEM, such as biology, chemistry and engineering 

Experience 

• 8+ years of Quality experience working in a GMP biotechnology manufacturing environment, ideally with hands-on experience in cell and/or gene therapy 

• 5+ years of effective management and strong leadership experience 

Knowledge & Skills 

• Subject matter expertise in Quality Systems in a GMP biotech setting 

• Preferred experience with Veeva Vault 

• Relevant phase-appropriate GMP experience 

Preferred Qualifications 

• Preferred ASQ certification