Director, Corporate Quality Management System (QMS)

About the role

The Director, Corporate QMS is a senior Quality executive responsible for establishing, leading, and continuously improving the global Quality Management System (QMS) across the Integra Lifesciences' organization of design, manufacturing, and distribution sites worldwide. This role has full enterprise accountability for ensuring that the corporate QMS is strategically designed, effectively deployed, and consistently executed across all global sites, while maintaining full compliance with FDA medical device regulations (21 CFR Part 820), MDSAP requirements, ISO 13485, and other applicable international standards.

Responsibilities

• Own and execute the global QMS strategy, ensuring integration of document and record control, training administration, and management control processes
• Define the strategy for a global QMS, and develop and maintain a unified global QMS aligned with business strategy and regulatory requirements
• In coordination and collaboration with the Enterprise Compliance Master Plan (ECMP), drive standardization, harmonization, and scalability of QMS processes across ~20 global sites with FDA-registered and/or ISO-certified quality management systems
• Establish corporate governance for QMS processes and ensure consistent deployment and adherence
• Lead enterprise QMS transformation initiatives, including process redesign and system enhancements
• Ensure full compliance with FDA 21 CFR Part 820, ISO 13485, MDSAP, EU MDR, and other global regulatory requirements
• Serve as a senior Quality authority and point person for regulatory inspections, communications, and compliance strategy
• Monitor evolving regulations and proactively implement changes across the QMS
• Establish and maintain inspection readiness programs across all sites
• Serve as the Quality Management Representative and Site Quality Leader for the Princeton, NJ facility
• Leveraging the Corporate Quality Compliance team, ensure the site maintains continuous audit readiness for FDA inspections and Notified Body audits
• Lead all regulatory inspections (FDA, ISO, MDSAP), including preparation, hosting, and response coordination
• Oversee site-level quality processes, ensuring alignment with corporate QMS and regulatory expectations
• Own and maintain the Enterprise-wide Quality Policy, Quality Manual, and corporate quality objectives
• Define, oversee, and revise quality metrics and performance monitoring systems
• Lead monthly data review board process; lead quality management review processes at Princeton site, divisional, and corporate levels
• Ensure robust governance, escalation, and decision-making frameworks for quality performance
• Lead, execute, and provide expert guidance on enterprise Quality initiatives with significant regulatory complexity, including FDA Warning Letter responses, Form 483 observations, Recall/field action activities, enterprise-wide QMS change programs, manufacturing site remediation efforts involving complex CAPAs, and high-risk Quality remediation initiatives
• Act as a senior Quality authority for interactions with global regulatory agencies, ensuring proactive regulatory risk management, inspection readiness, and sustainable compliance. Provide executive-level guidance on enforcement actions, remediation strategies, and regulatory commitments
• Partner closely with the Quality PMO, Post-Market Quality, Quality Assurance, and Quality Compliance organizations to directly support and influence programs under their ownership. Ensure disciplined execution, cross-functional alignment, risk management, and achievement of critical milestones
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration and remediation strategies
• Lead and support Quality due diligence activities for mergers, acquisitions, and strategic partnerships. Assess Quality system maturity, regulatory risk, and remediation needs, and provide post-acquisition integration