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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 riskbased decision making.

This leader will define and execute a global supplier quality strategy, drive enterprisewide 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 supplierrelated outcomes during regulatory inspections, notified body audits, and health authority engagements.

• Oversee supplier audit strategy, qualification, monitoring, and remediation activities, including highrisk and critical suppliers.

• Drive robust investigation, CAPA, and systemic issue resolution related to supplier and external manufacturing performance.

Operational Excellence & Risk Management

• Implement riskbased 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 subjectmatter experts across regions and manufacturing models.

• Set clear priorities, performance expectations, and development plans to build a highperforming supplier quality organization.

• Foster a culture of accountability, collaboration, and continuous improvement consistent with enterprise quality values.

CrossFunctional & 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 boardlevel 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, multisite 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 enterpriselevel transformations, remediation programs, or quality system harmonization initiatives.

Key Competencies

• Executive leadership and influence

• Global regulatory and supplier quality expertise

• Riskbased decision making

• Strategic thinking and change leadership

• Strong collaboration across complex matrix organizations

• Datadriven performance management

Salary Pay Range:

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/

Integra LifeSciences 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.
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Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

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