Landmark Bio

Director

• Own the strategy, design and continuous improvement of the Quality Management System
• Establish and maintain the quality manual, quality policies and governing procedure hierarchy
• Own core quality systems including documentation management, training, deviations, CAPA, effectiveness checks, change control, supplier quality and change management, quality risk management, and audit management
• Implement a quality risk management program consistent with ICH Q9(R1)
• Ensure compliance with applicable regulations and guidance documents
• Lead supplier, client and internal audit readiness programs
• Support front-room and back-room audits and oversee audit responses
• Own the internal audit program, including annual planning, execution, reporting and CAPA follow-up
• Oversee supplier qualification and monitoring, including risk-based supplier audits and performance management
• Define, trend and report key quality metrics and indicators
• Lead quality management reviews and escalate significant compliance risks to senior leadership
• Build, lead and develop the Quality Systems team, including recruiting, performance objectives, coaching and career development
• Manage and own the Change Control Review Board
• Partner with cross-functional stakeholders to foster a strong Culture of Quality
• Drive timely closure of quality records

Associate Director – Quality Systems