Director of Global Supply Network Excellence

Role Overview

• Lead, develop, and inspire a team of Quality professionals to achieve organizational and individual performance objectives.
• Establish clear priorities, assign responsibilities, and ensure effective resource allocation to meet business and compliance needs.
• Provide technical, regulatory, and operational leadership to ensure Quality systems comply with ISO 13485, FDA 21 CFR 820, IVDR, and other applicable requirements.
• Management Responsibility as required by ISO13485/9001 and ensuring specific economic operator roles are fulfilled.
• Drive harmonization and standardization of Quality processes, procedures, and tools across sites and functions to strengthen compliance and efficiency.
• Partner with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle.
• Promote a culture of continuous improvement by identifying opportunities for simplification, process excellence, and digital enablement within the Quality Management System (QMS).
• Ensure the team maintains a state of inspection readiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits.
• Monitor Quality performance using metrics and data analytics to identify risks, drive root cause analysis, and implement sustainable improvements.
• Coach and mentor emerging Quality leaders and technical experts to build organizational capability and ensure robust succession planning.
• Communicate Quality and Compliance strategy, progress, and risk mitigation plans to senior leadership and cross-functional stakeholders.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline required
• 12+ years’ experience in Medical Device quality system management
• Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR
• Experience/knowledge of Supplier Quality Management Processes, auditing, Change Management, Root Cause Analyses, Corrective/Preventive Actions
• Experience/knowledge with distribution processes, logistics and supply chain operations
• Proven ability to lead and develop high-performing teams and build future technical and people leaders.
• Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations.
• Excellent collaboration, influence, and communication skills across functional and organizational boundaries.
• Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement.
• Experience leading in a matrixed, global organization and managing competing priorities effectively.
• Commitment to scientific integrity, compliance excellence, and continuous improvement.

Benefits

• medical, dental, vision, life, and disability insurance
• 401(k) plan
• employee assistance program
• Employee Stock Purchase Plan
• paid time off (including sick time) and paid Holidays