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 whats 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 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

• Bachelors 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 (Masters).

• 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 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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