SVP Quality Systems

Job Summary

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.

MAJOR RESPONSIBILITIES

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.

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.

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-based quality culture focused on product quality, patient safety, compliance, and operational effectiveness.

Lead, organize, plan, direct, staff, coordinate, and communicate across senior leaders and teams responsible for the function to execute business plans and required organizational changes. Set performance standards, establish clear decision rights and accountability, monitor performance, develop talent, and maintain appropriate staffing and capabilities. Build an environment of open communication, collaboration, disciplined execution, and continuous improvement.

Typically requires a Bachelor's degree in Engineering, Quality Assurance, Life Sciences, Regulatory Affairs, Business, or a related field.

Professional quality or regulatory certification preferred, as applicable to the function.

At least 15 years of progressively responsible experience in Quality Assurance, Regulatory Affairs, Quality Engineering, or a related function within medical device, pharmaceutical, healthcare products, or another highly regulated industry.

At least 10 years of progressively responsible people‑leadership experience, including leading senior leaders and complex, multi‑site or global organizations.

At least 5 years of executive‑level experience at the Vice President level or above with responsibility for enterprise outcomes, cross‑functional execution, organizational capability, and succession planning.

Deep knowledge of applicable FDA requirements, ISO 13485, EU MDR, and other global quality and regulatory requirements relevant to the function. Executive leadership skills with demonstrated ability to set strategy, govern complex portfolios, allocate resources, and drive accountable…