Director, Quality Assurance - Regulatory

About this role

Labcorp is a global leader in laboratory services, providing the insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies and health systems make confident decisions and improve outcomes. Through our unparalleled science, data, technology and laboratory network, we advance diagnostics, accelerate innovation and help address some of the world’s most important health challenges. As we shape the future of healthcare, we are leveraging advanced technologies, intelligent digital solutions and data-driven innovation across our operations to enhance how work gets done and deliver greater value to customers and patients. With our global scale and deep expertise, you’ll have the opportunity to do meaningful work, grow your career and make a real impact on people’s health around the world. Together, we’re improving health and improving lives.

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.

Preferred Qualifications: • 3 or more years of experience in medical device Quality Management System activities. 

• 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.

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!

Pay Range: $130,000 - $150,000 annually (USD) All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. The position is also eligible for an annual bonus under the Labcorp Bonus Plan. Bonuses are payable based on corporate and/or business segment performance and are subject to individual performance modifiers.

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