Global Supplier Quality System Professional

Key Responsibilities

• Lead and execute the global Vendor Change Notification (VCN), Supplier Change Management, and Supplier Quality Agreement (SQA) programs.
• Ensure supplier-initiated changes are identified, reviewed, approved, and implemented in accordance with Quality Management System (QMS) requirements, Supplier Quality Agreements, and regulatory expectations.
• Develop, negotiate, implement, maintain, and periodically review Supplier Quality Agreements to ensure clear definition of quality responsibilities, change notification requirements, regulatory compliance obligations, escalation processes, record retention requirements, and supplier performance expectations.
• Maintain and continuously improve supplier change management and Supplier Quality Agreement procedures, policies, templates, and governance processes to ensure consistency, compliance, and effectiveness across the supplier network.
• Evaluate supplier change notifications for potential impact to product quality, patient safety, regulatory compliance, manufacturing processes, and supply continuity.
• Coordinate cross-functional reviews involving Quality, R&D, Engineering, Operations, and Procurement to assess, approve, and implement supplier changes.
• Review supplier changes against Supplier Quality Agreement requirements to ensure all notification, approval, and compliance obligations are fulfilled.
• Maintain supplier change records and ensure traceability throughout the change lifecycle.
• Serve as the business owner and subject matter expert for the Supplier Quality Agreement program.
• Negotiate, execute, renew, and maintain Supplier Quality Agreements across the supplier lifecycle.
• Conduct periodic reviews of Supplier Quality Agreements to ensure alignment with current regulatory requirements, quality system expectations, organizational policies, and supplier capabilities.
• Drive resolution of quality agreement gaps, deviations from contractual requirements, and compliance concerns through collaboration with suppliers and internal stakeholders.
• Maintain Supplier Quality Agreement documentation, records, metrics, and governance processes to support audit readiness and inspection preparedness.
• Monitor supplier compliance with change notification requirements and Supplier Quality Agreement obligations, including timeliness, completeness, and effectiveness.
• Track key performance indicators (KPIs) related to supplier change management, and quality agreement compliance.
• Analyze trends in supplier changes, audit observations, quality events, and contractual compliance metrics to identify emerging risks and improvement opportunities.
• Drive continuous improvement initiatives that enhance supplier quality governance and regulatory compliance.
• Ensure supplier change management and Supplier Quality Agreement activities comply with applicable regulatory and quality requirements, including ISO 13485, FDA 21 CFR Part 820/QMSR, GMP, and other relevant standards.
• Support internal audits, external audits, customer audits, and regulatory inspections related to quality agreements and change management processes.
• Serve as the primary Supplier Quality representative for supplier change management and Supplier Quality Agreement activities across global functions.
• Collaborate with R&D, Engineering, Regulatory Affairs, Operations, Manufacturing, Procurement, and Legal to evaluate supplier risks, change impacts, and contractual quality requirements.
• Facilitate cross-functional decision-making and risk assessments to support timely implementation of supplier changes and quality agreement requirements.
• Build strong partnerships with suppliers to ensure proactive communication, effective governance, and management of quality and compliance risks.
• Lead or contribute to global initiatives focused on harmonizing supplier change management and Supplier Quality Agreement programs.
• Influence supplier and internal stakeholder decisions through risk-based assessments, quality data, contractual requirements, and compliance-focused recommendations.
• Provide guidance, training, and subject matter expertise on supplier change management, and Supplier Quality Agreement requirements across the organization.
• Plan, conduct, and lead supplier audits (qualification, surveillance, and for-cause audits).
• Assess supplier adherence to contractual change notification requirements, Supplier Quality Agreements, and applicable regulatory standards.
• Identify gaps in supplier quality systems and drive timely remediation through audit findings, corrective actions, and continuous improvement initiatives.
• Support supplier qualification and ongoing oversight activities through risk-based audit planning and execution.
• Verify supplier compliance with quality agreement commitments during audits and supplier performance reviews.

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 vendor change notifications, 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.

Preferred Qualifications

• Six Sigma Green/Black Belt.
• Experience in medical device, pharmaceutical, or other highly regulated industries.
• Experience working with Supply Chain and/or Procurement.