Sr. Global Supplier Quality Professional

Key Responsibilities

• Execution of global supplier quality strategies, policies, and procedures across regions and business units
• Ensure alignment of supplier quality processes with Quality Management System (QMS) requirements and regulatory standards
• Partner with Global Supply Chain and Procurement to establish supplier segmentation, risk classification, and oversight models
• Auxiliary in supplier selection, qualification, onboarding, and inclusion in Approved Supplier Lists (ASL)
• Conduct and/or lead supplier audits (initial, surveillance, for-cause) to assess compliance with quality and regulatory standards
• Auxiliary in maintaining supplier quality agreements, specifications, and performance expectations
• Maintain key supplier performance metrics (e.g., defect rates, on-time delivery, cost of poor quality)
• Identify performance trends and drive continuous improvement initiatives with suppliers
• Execute the supplier development programs to improve process capability, reduce variability, and enhance product quality
• Represent Global Supplier Quality in root cause investigations and resolution of supplier quality issues using structured problem-solving methodologies (e.g., 8D, DMAIC)
• Drive Supplier Corrective and Preventive Actions (SCAR/CAPA) and verify effectiveness of implemented actions
• Execute non-conformances, deviations, and escalation processes across global supply base
• Ensure supplier controls meet applicable regulatory requirements (e.g., ISO 13485, FDA, GMP)
• Support internal and external audits, inspections, and regulatory submissions related to supplier quality
• Maintain audit readiness through proper documentation, traceability, and quality records
• Partner with R&D, Engineering, and Operations on new product development and supplier integration activities
• Provide supplier quality input into design controls, risk management, and validation activities
• Work cross functionally with internal stakeholders and global suppliers
• Mentor junior supplier quality professionals and provide technical guidance across the organization
• Participate in cross-functional and cross-regional initiatives to drive harmonization and best practices
• Influence decision-making through data-driven insights and supplier performance analytics

Requirements

• Bachelor’s degree in life sciences, engineering, or related field required; advanced degree preferred
• 8+ years of progressive quality experience in Supplier Quality, Quality Engineering, or Quality Systems in a regulated industry
• Demonstrated experience working with global suppliers and cross-regional teams
• Strong knowledge of Quality Management Systems (QMS) and supplier controls
• Experience with regulatory standards such as ISO 13485, ISO 9001, FDA 21 CFR Part 820, and/or GMP requirements
• Proficiency in quality tools and methodologies (e.g., FMEA, SPC, process validation, statistical analysis)
• Experience managing supplier audits, CAPA systems, and change control processes
• Advanced problem-solving and root cause analysis capabilities
• Strong project management skills with ability to manage multiple initiatives globally
• Excellent communication and stakeholder management skills across technical and non-technical audiences
• Ability to influence without authority and drive accountability across a global supply base
• High level of analytical capability with experience interpreting supplier performance data
• Willingness to travel globally up to 30%