Director, Corporate Quality Management System (QMS)

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 what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

SUMMARY DESCRIPTION

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.

SUPERVISION RECEIVED

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

SUPERVISION EXERCISED

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

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

• Strategic Quality Leadership

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.

Regulatory & Compliance Excellence

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.

Program & Execution Oversight

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.

Due Diligence & Integration Support

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.

Leadership & Influence

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.

QUALIFICATIONS

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 writing and interpersonal relationship skills

Key Competencies

Strategic thinking, strong execution discipline, executive presence, exceptional communication skills, collaboration in complex environments, and an unwavering commitment to patient safety, product quality and:

• 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

Additional Qualifications

• 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

• Willingness to travel (up to ~25%)

TOOLS AND EQUIPMENT USED

Ability to utilize a computer, telephone, copier, fax machine as well as other general office equipment, and industry-standard Quality System applications

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include but are not limited to the motor/physical abilities and skills require of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, and be able to travel by automobile or airline to Integra offices internationally as well as domestically. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 25lbs.

ADVERSE WORKING CONDITIONS

The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment.

SELECTION GUIDELINES

Formal application, rating of education and experience; oral interview and reference check; job related tests may be required.

DISCLAIMER

The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.

The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.

Salary Pay Range:

$166,750.00 - $228,850.00 USD Salary

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 Total Rewards | Integra LifeSciences

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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Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.

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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