Director, Site Quality

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

SUMMARY

The Site Quality Leader is responsible for overseeing all quality and compliance activities at the Columbia manufacturing site and CMOs. This role provides strategic and operational quality leadership to ensure adherence to corporate policies and regulatory requirements. This leader will ensure robust quality systems adherence to and efficiencies in quality processes improve inspection readiness and oversee quality for external manufacturers.
Reporting to the VP Quality Operations TT division the Site Quality Leader serves as the primary quality authority for the site ensuring product quality regulatory compliance and alignment with the companys Compliance Master Plan (CMP) and Quality Management System (QMS).

ESSENTIAL DUTIES AND RESPONSIBILITIES

Quality Leadership & Strategy

• Provide strategic direction for all site quality functions ensuring alignment with corporate quality objectives and regulatory expectations.

• Drive the timely execution of critical corporate initiatives and programs.

• Lead the development implementation and continuous improvement of site quality systems processes and metrics.

• Serve as the sites senior quality representative during regulatory inspections internal audits and customer audits.

• Champion a culture of quality compliance and operational excellence across all site functions.

Quality Systems & Compliance

• Ensure full compliance with FDA ISO 13485 CMDR EU MDR JPAL and other applicable regulations.

• Oversee the effectiveness of key quality system elements including CAPA nonconformance management change control document control internal audits training and risk management.

• Drive timely and effective remediation of quality and compliance gaps including those identified through the Compliance Master Plan (CMP).

• Ensure robust supplier quality oversight in partnership with corporate Supplier Controls leadership.

Manufacturing Quality Oversight

• Provide leadership for incoming inspection inprocess quality final release and product disposition activities.

• Ensure that manufacturing processes are validated controlled and monitored to maintain product quality and regulatory compliance.

• Partner with Operations Engineering and Supply Chain to proactively identify risks implement corrective actions and improve process capability.

CrossFunctional Collaboration & Stakeholder Management

• Collaborate with Regulatory Affairs R&D Operations Supply Chain and corporate Quality teams to ensure alignment and consistency across the organization.

• Communicate quality performance risks and improvement plans to site leadership and executive stakeholders.

• Influence and guide crossfunctional teams to ensure quality considerations are embedded in all business decisions.

People Leadership & Development

• Lead mentor and develop a highperforming site quality team including Quality Engineering Quality Assurance and Quality Control functions.

• Ensure the team has the skills tools and resources needed to meet quality and compliance objectives.

• Foster a collaborative accountable and continuousimprovementoriented environment.

Performance Management & Reporting

• Establish and maintain site quality metrics dashboards and reporting mechanisms.

• Monitor trends identify systemic issues and drive datadriven improvements.

• Provide regular updates to senior leadership on site quality performance risks and strategic initiatives.

QUALIFICATIONS

• Bachelors degree in Engineering Life Sciences Quality Management or related technical field; Masters degree preferred.

• Minimum 1215 years of experience in quality manufacturing or engineering within a regulated industry; medical device experience strongly preferred.

• Demonstrated success leading quality teams and managing complex quality systems in FDAregulated environments. Remediation and audit readiness experience preferred.

• Deep knowledge of cGMP FDA regulations ISO 13485 MDSAP EU MDR and other global regulatory frameworks.

• Strong background in CAPA root cause analysis risk management and process validation.

• Proven ability to lead crossfunctional teams influence stakeholders and drive largescale quality improvements.

• Excellent analytical problemsolving communication and presentation skills.

• Ability to manage multiple priorities in a fastpaced environment.

• Up to 2540% travel may be required depending on site and corporate needs.

LEADERSHIP CAPABILITIES

• Enterprise Mindset: Makes decisions that support the broader organization not just the site.

• Thought Leadership: Applies deep quality expertise to influence strategy and drive innovation.

• Drive Performance: Holds self and others accountable for delivering highquality results.

• Enable Talent: Builds strong teams develops future leaders and fosters engagement.

Salary Pay Range:

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 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 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 candidates 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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