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