• Lead the development and execution of global GMP quality engineering strategies aligned with regulatory expectations and business objectives. • Serve as the organizational lead for Quality Risk Management (QRM), establishing risk-based approaches to identify, evaluate, and mitigate quality and compliance risks. • Drive continuous improvement (CI) initiatives using tools such as Lean, Six Sigma and root cause analysis to improve product quality, process robustness, and operational efficiency. • Oversee the enhancement and maintenance of core quality systems (e.g., CAPA, deviation management, change control, batch release, investigations) to ensure effectiveness and inspection readiness. • Strengthen data integrity controls and drive global initiatives to ensure compliance with ALCOA+ principles. • Lead quality oversight for manufacturing activities, tech transfer, scale-up, validation, and commercial production to ensure end-to-end GMP compliance. • Provide strategic direction during regulatory inspections (FDA, EMA, MHRA, PMDA) and internal audits; ensure timely resolution of observations and sustainable remediation. • Collaborate cross-functionally with Manufacturing, QC, Regulatory Affairs, Supply Chain, and Commercial teams to embed quality into operational decision-making and strategic planning. • Develop and implement risk-based monitoring and metrics to proactively assess performance and compliance trends. • Guide quality input for new product introductions (NPI), clinical and commercial launches, and global supply chain strategies to ensure product availability and regulatory alignment. • Lead and mentor a global team of quality engineers and specialists; build capabilities through training, coaching, and talent development. • Represent the Quality function in strategic business forums and quality governance meetings; act as a key quality liaison to executive leadership and health authorities. • Foster a culture of quality excellence, ownership, and continuous learning throughout the organization.