Senior Director, Supplier & External Manufacturing Quality

Changing lives. Building Careers.
 

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

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.

Job Description

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

• Represent Supplier & Contract Manufacturing Quality in enterprise quality reviews, management reviews, and board‑level discussions, as required.

Education & Experience

Required

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.

• 15+ years of progressive experience in Quality within the medical device or regulated life sciences industry, including significant supplier or external manufacturing oversight.

• Demonstrated leadership experience managing global, multi‑site organizations and complex external partner networks.

• Expect 30%+ Travel

Preferred

• Advanced degree (Master’s).

• Deep working knowledge of global regulatory frameworks impacting supplier and contract manufacturing quality.

• Proven success leading enterprise‑level transformations, r