Director, Corporate Quality Management System (QMS)

Integra LifeSciences•Princeton, NJ

1d•$166,750 - $228,850•Onsite

About The Position

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.

Requirements

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
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 writing and interpersonal relationship skills
Strategic thinking, strong execution discipline, executive presence, exceptional communication skills, collaboration in complex environments, and an unwavering commitment to patient safety, product quality
Strategic leadership and systems thinking
Executive-level judgement, independence and decision-making
Strong program execution and operational discipline
Advanced hands-on problem-solving and systemic root cause analysis
Ability to influence without authority in complex, matrixed environments
Exceptional communication and stakeholder management skills
Proven ability to lead under regulatory pressure and ambiguity
Strong experience with enterprise QMS software deployment and validation
Proven success in global process standardization initiatives
Ability to interface effectively with technical and non-technical stakeholders
Strong organizational, prioritization, and multitasking abilities
Strong oral and written communication skills and effective interpersonal skills
Proficiency in Microsoft Office and quality systems tools

Nice To Haves

Willingness to travel (up to ~25%)

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
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
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
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
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
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
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
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.