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Job Description Summary
The Senior Director, Supplier & External Manufacturing Quality is responsible for providing global strategic leadership and governance for supplier quality management and contract manufacturing quality across the enterprise. This role ensures that external manufacturing partners, critical suppliers, and service providers consistently meet regulatory, quality, and business requirements while enabling operational excellence, scalability, and risk-based decision making.
This leader will define and execute a global supplier quality strategy, drive enterprise-wide standardization, and partner closely with Supply Chain, R&D and Regulatory Affairs to ensure product safety, compliance, and continuity of supply across the product lifecycle.
Global Supplier & Contract Manufacturing Quality Strategy
Establish and execute a global strategy for supplier quality and contract manufacturing quality aligned with corporate quality objectives and business growth priorities.
Define governance models, performance expectations, and escalation pathways for external manufacturing and supplier quality risk.
Serve as the Quality leader for supplier quality management across new product introduction (NPI), lifecycle management, and acquisitions.
Lead transformation initiatives to mature supplier quality systems, analytics, and risk management capabilities.
Regulatory Compliance & Inspection Readiness
Ensure supplier and contract manufacturer compliance with FDA, ISO 13485, EU MDR, MDSAP, and other global regulatory requirements.
Act as the quality leader accountable for supplier-related outcomes during regulatory inspections, notified body audits, and health authority engagements.
Oversee supplier audit strategy, qualification, monitoring, and remediation activities, including high-risk and critical suppliers.
Drive robust investigation, CAPA, and systemic issue resolution related to supplier and external manufacturing performance.
Operational Excellence & Risk Management
Implement risk-based supplier segmentation and performance management frameworks.
Lead enterprise programs for supplier change management, process validation, PPAP/FAI, and ongoing supplier process monitoring.
Partner with Supply Chain to proactively manage quality, compliance, and continuity of supply risks.
Leverage data and analytics to drive predictive insights, trend analysis, and continuous improvement.
Leadership & Talent Development
Provide leadership to a global organization of senior managers, managers, and subject-matter experts across regions and manufacturing models.
Set clear priorities, performance expectations, and development plans to build a high-performing supplier quality organization.
Foster a culture of accountability, collaboration, and continuous improvement consistent with enterprise quality values.
Cross-Functional & Engagement
Serve as a key advisor to executive leadership on supplier quality risk, external manufacturing strategy, and regulatory exposure.
Influence and align senior stakeholders across Quality, Operations, Supply Chain, R&D, Regulatory.
Education & Experience
Required:
Preferred:
Key Competencies
Salary Pay Range: $192,050.00 - $263,350.00 USD
Salary Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following https://jobs.integralife.com/total-rewards/