Director, Corporate Quality Management System (QMS)

Director, Corporate QMS

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.

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.

In addition to enterprise leadership, this position serves as the Site Quality Leader (SQL) for the Princeton, NJ corporate office, an FDA-registered and ISO 13485-certified facility. The Director ensures the site is continuously audit-ready, leads all regulatory inspections, and oversees site-level quality system execution and compliance.

The role leads global teams responsible for document control, training administration, management controls, technical writing, and regulatory response management, and acts as a key advisor to executive leadership on Quality strategy, compliance risk, and business performance.

Under the direct supervision of the VP / Functional Quality Leader.

Direct leadership of Corporate QMS functions including:

• Document Control & Records Management
• Training Administration
• Management Controls (Quality Policy, Objectives, Planning, Metrics, Management Reviews)
• Technical Writing & Regulatory Response Team

Indirect leadership across global site Quality and Supply Chain team members and cross-functional global stakeholders.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

1. Enterprise QMS Strategy & Leadership

• 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

2. Regulatory Compliance & Global Standards

• 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

3. Princeton Site Quality Leadership

• 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

4. Management Controls (Corporate Quality Governance)

• Own and maintain the Enterprise-wide Quality Policy, Quality Manual, and corporate quality objectives
• Maintain enterprise quality planning processes aligned with strategic business goals
• 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

5. Document Control, Change Control & Records Management

• Lead the global and site-based document and records control program ensuring compliance, consistency, and efficiency
• Oversee change control processes for the QMS, ensuring risk-based prioritization and execution
• Ensure lifecycle management of quality documentation across systems and sites
• Maintain corporate record retention and archiving programs

6. Training Administration & LMS

• Own the global Quality System training program for global documents
• Ensure compliance with training requirements, including 21 CFR Part 11 where applicable
• Drive training effectiveness through metrics, audits, and continuous improvement

7. Regulatory Response & Technical Writing

• Leveraging the Technical Writing team, lead development and submission of timely regulatory responses, including FDA 483 observations and Warning Letter updates
• Oversee technical writing for QMS documentation and compliance communications
• Ensure high-quality, timely, and accurate regulatory documentation aligned with agency expectations

8. Audit Readiness & Inspection Management

• Leveraging the Corporate Quality Compliance team, establish and maintain a state of continuous audit readiness for the corporate site
• Ensure the completion of required site-level internal audits and host external inspections and audits
• Ensure timely and effective response to audit findings, including CAPA and overall action effectiveness

9. Quality Systems Performance & Continuous Improvement

• Partnering with Quality Compliance Program Management, monitor QMS performance through data analytics and key performance indicators
• Drive continuous improvement initiatives across all QMS processes
• Identify systemic issues and lead root cause analysis and corrective actions

10. Leadership & Organizational Effectiveness

• Build and lead high-performing global teams
• Provide coaching and technical leadership across QMS disciplines
• Influence senior leadership and cross-functional teams
• Foster a culture of quality, compliance, and operational excellence

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.

Serve 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.

Act as a mentor and leader to senior Quality professionals, influence effectively in matrixed environments, and build strong partnerships with executive leadership to support informed decision-making.

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

Education and Experience

• Bachelor's degree in engineering, life sciences, or a related technical discipline
• 15+ years of progressive Quality experience within medical devices or similarly regulated life sciences industries
• Demonstrated, hands-on leadership of FDA remediation efforts, including Warning Letters or other enforcement actions
• Extensive experience in QMS design, deployment, and transformation

Knowledge and Expertise

• Deep working knowledge of FDA QMSR / 21 CFR 820, FDA inspection and enforcement processes, ISO 13485 and global standards and regulatory frameworks
• Expertise in document control, training systems, change management, and records management
• Strong understanding of Management Controls, CAPA, audits, and compliance systems
• Experience with QMS technologies (TrackWise, LMS, Agile or equivalent)
• Strong analytical skills, exceptional