SVP Quality Systems

About the role

Provide enterprise leadership for the global Quality Management System and its core processes, including post-market surveillance and quality technology, to ensure compliant, harmonized, data-enabled, and sustainable quality operations. The role establishes functional strategy, governance, performance expectations, and organizational capability while partnering across Quality, Regulatory Affairs, Operations, R&D, Supply Chain, Legal, Commercial, and business leadership as relevant to the function. The leader is accountable for effective execution, timely escalation, and sustainable compliance with applicable requirements.

Responsibilities

• Global QMS Governance: Provide executive leadership over the global Quality Management System, ensuring compliance with FDA regulations, ISO standards, and applicable global requirements. Identify and partner with Global Process Owners to define, harmonize, govern, and continuously improve common quality processes. Establish QMS governance, management review, metrics, escalation, and accountability across sites and business units.
• Post-Market & Quality Technology: Provide executive oversight for Post-Market Surveillance, including complaint handling, signal detection and trending, adverse event reporting, and integration of post-market data into risk management. Define and lead the quality technology strategy, including enterprise quality systems, quality data, analytics, AI, and automation. Ensure quality systems are selected, implemented, validated, maintained, and improved in alignment with business and regulatory needs.
• Organizational Leadership: Lead and develop leaders who own core QMS functions, ensuring consistent capability, resourcing, and accountability. Partner with Product Quality, Operations Quality, Regulatory Affairs, IT, Legal, and business leaders to drive adoption and sustainable execution. Promote a proactive, risk