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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.
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
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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EEO Is the Law | EOE including Disability/Protected Veterans
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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