Director, Global Quality Management System & Risk Management

Position Summary:

The Director, Global Quality Systems (QMS) & Risk Management is a key leadership role within Global Quality Operations, responsible for setting the strategic direction and ensuring operational excellence across core quality system areas: QMS & Risk Management; Product Complaints; Quality Events (Deviation, CAPA, Change Control); and Digital QMS Governance. This role provides strategic oversight and execution of quality systems that ensure compliance with global regulatory requirements, support continuous improvement, risk management, and align with business objectives. The Director will be responsible for cross-functional governance, monitor and enhance key quality and corporate metrics, and drive data-informed decision-making through robust analytics and trending. With accountability for the digital QMS roadmap and quality systems lifecycle, this leader will shape scalable, solutions and improvements that enable stakeholder adoption, and a proactive quality culture. The Director will serve as a business owner, cross-functional collaborator, and subject matter expert—ensuring quality processes remain aligned, agile, and effective in supporting global operations.

Key Responsibilities Include:

QMS & Risk Management Oversight

• Responsible for the cross-functional QMS Process, Record and Change Owners governance, promoting collaboration and system-wide consistency.
• Direct the Quality Management Review (QMR) program, including development of key metrics, dashboards, and actionable readouts.
• Monitor and manage the assessment of regulatory changes to proactively adjust the QMS strategy and maintain compliance and manage risk.
• Own the performance of key QMS metrics and partner across functions to ensure achievement of quality objectives.
• Align QMS strategies with business needs and act as a key liaison between Quality and cross-functional departments.

Quality Events (Deviation, CAPA, and Change Control Management)

• Provide strategic and operational leadership of the global deviation, CAPA, and change control programs.
• Establish and maintain robust, fit-for-purpose processes, workflows, and digital tools for managing Quality Events.
• Oversee governance forums and provide oversight to ensure consistency, timely closure, and effectiveness of root cause investigations and CAPAs.
• Develop and maintain analytics and trending dashboards to identify systemic issues and drive continuous improvement and risk management.
• Ensure timely fulfillment of inspection and audit-related commitments within the QMS.

Product Complaints Management

• Provide strategic and operational leadership for the global Product Complaints program, ensuring timely triage, thorough investigation, risk assessment, and resolution in alignment with regulatory and business requirements.
• Oversee the governance structure, including triage boards and complaint review committees, to drive accountability, ensure cross-functional collaboration, and maintain consistency in decision-making and escalation processes.
• Ensure end-to-end procedural compliance, from intake through closure, by establishing and monitoring robust processes, quality records, and system controls across all complaint handling stages.
• Drive the development and execution of complaint trending and analytics, identifying signals, systemic issues, and areas for continuous improvement, while ensuring readiness for regulatory inspections and external audits.
• Collaborate with internal partners and external stakeholders to assess product impact and enable timely, effective responses to potential risks.
• Support global reporting and market-specific requirements in alignment with regulatory reporting obligations and timelines.
• Maintain an inspection-ready at all times through proactive governance, training, periodic audits, and continuous enhancement of the complaint handling framework.

 Additional Responsibilities

• Oversee the digital QMS governance model and roadmap to support activities across all eQMS systems phases, ensuring alignment with business needs.
• Oversee the organizational training and support for global quality system processes.
• Establishes a communication strategy for QMS Support, key messages, and management of escalations.
• Ability to think strategically and maintain attention to detail.
• Lead, develop, and mentor a team of quality professionals responsible for key QMS elements, fostering a culture of accountability, collaboration, and continuous improvement.
• Serve as a subject matter expert and leader during inspections and audits.
• Manage contracts and bu