Senior Director, Supplier & External Manufacturing Quality

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The Senior Director, Supplier & External Manufacturing Quality provides 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.

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.

Ensure supplier and contract manufacturer compliance with FDA, ISO
13485, EUMDR, 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.

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.

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.

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.

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. 30%+ Travel.

Advanced degree (Master’s). Deep working knowledge of global regulatory frameworks impacting supplier and contract manufacturing quality. Proven success leading enterprise‑level transformations, remediation programs, or quality system harmonization initiatives.

• Executive leadership and influence
• Global regulatory and supplier quality expertise
• Risk‑based decision making
• Strategic thinking and change leadership
• Strong collaboration across complex matrix organizations
• Data‑driven performance management

$ – $ USD. Salary ranges are determined by role, level, and location. Base pay, bonus, commission, equity, or other variable compensation may be available. Your recruiter can provide additional detail during the hiring process.

• Medical
• Dental
• Vision
• Life insurance
• Short‑term & long‑term disability
• Business accident insurance
• Group legal insurance
• 401(k) savings plan

Integra Life Sciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. All policies comply with applicable U.S. laws and regulations. If you need accommodations due to disability, please email