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Labcorp is seeking a Director, Quality Assurance – Regulatory to join our team in either Burlington or Durham, NC!

Work Schedule: 1st shift with hybrid work model on site either at the Burlington or Durham, NC office.

Job Responsibilities:

The Director, Quality Assurance-Regulatory supports Labcorp’s Enterprise Kit Collection Quality Management System (QMS) and provides strategic and operational quality leadership for an enterprise-wide specimen collection kit program. They are accountable for the design, implementation, governance, and continuous improvement of a compliant quality management system supporting the lifecycle of specimen collection kits used across diagnostic and clinical programs. This position allows the opportunity to build a quality system with high visibility within the organization.

Provide quality governance for specimen collection kits used across Labcorp, ensuring compliance with FDA medical device regulations, ISO 13485 and other regional requirements as applicable.
Serve as the Management Representative and host of regulatory inspections, internal and external audits.
Design, implement, and maintain a robust Quality Management System for the centralized specimen collection kit program, including policies, procedures, and controls aligned with regulatory and business needs.
Align feedback and complaint handling processes and post market surveillance practices for specimen collection kits across Labcorp.
Serve as Quality subject matter expert for specimen collection kits, partnering closely with Regulatory Affairs to ensure aligned interpretation and application of regulatory and quality requirements, including regulatory registrations.
Oversee and ensure quality oversight of kit lifecycle processes including design controls, risk management, supplier qualification and oversight, manufacturing controls, labelling, change control, complaints, CAPA, record retention, reporting and recall readiness, management review and metrics reporting.
Provide quality oversight of external specimen collection kit manufacturers, including management of quality agreements, supplier audits, performance monitoring, and issue management.
Partner with cross-functional stakeholders (laboratory operations, sourcing and procurement, product development, R&D, science and technology, manufacturing partners, distribution, and commercial teams) to embed quality and compliance into day-to-day operations.
Drive a culture of quality, compliance, and continuous improvement across the enterprise kit program through coaching, influence, and collaboration.
Serve as a quality escalation point for kit-related issues, ensuring timely investigation, root cause analysis, and implementation of effective corrective and preventive actions.
Perform other duties as assigned by management.

Minimum Qualifications:

Bachelor’s degree in engineering, biology, molecular biology, biochemistry, chemistry.
15 or more years of experience in medical device quality, operations, or regulatory roles.
3 or more years of experience in medical device Quality Management System activities.

Preferred Qualifications:

ASQ or Six Sigma certification.
3 or more years of experience with Regulatory Affairs in medical device environment.
3 or more years of experience with FDA inspections and audits of medical device manufacturing or specification development.

Additional Job Standards:

Strong working knowledge of 21 CFR 820 and ISO 13485.
Expertise in quality system elements including CAPA, complaints, risk management, audits, supplier quality, and change control.
Excellent written and verbal communication skills, including the ability to.
Explain complex regulatory and quality concepts.
Ability to influence cross-functional teams without direct authority.
Strong strategic thinking and problem-solving, and high level of integrity, accountability, and commitment to quality excellence.

At Labcorp, you can expect the following:

Innovative Environment: Join a leading healthcare organization committed to driving innovation through internal development to help improve health and improve lives.
Collaborative Culture: Work in a dynamic, inclusive environment that values diverse perspectives and fosters collaboration.

Apply:

Director, Quality Assurance - Regulatory in Burlington, North Carolina, United States of America at Labcorp

If you have a passion for Quality and a drive for operational excellence, join our growing Quality team as a Director, Quality Assurance – Regulatory and take your career to the next level at Labcorp. Imagine having the freedom to create a Quality system and work closely with the Manufacturing kit collection team that changes the course of our industry daily!

Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Employees regularly scheduled to work less than 20 hours, Casual, Intern, and Temporary employees are only eligible to participate in the 401(k) Plan. Employees who are regularly scheduled to work a 7 on/7 off schedule are eligible to receive all the foregoing benefits except PTO or FTO.

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