Director, Quality Assurance - Regulatory

Labcorp•Burlington, NC

1d•$130,000 - $150,000•Hybrid

About The Position

Labcorp is seeking a Director, Quality Assurance – Regulatory to join their team in either Burlington or Durham, NC. This role 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. The position is 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 role offers the opportunity to build a quality system with high visibility within the organization. Labcorp is a global leader in laboratory services, providing insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies, and health systems make confident decisions and improve outcomes. They are leveraging advanced technologies, intelligent digital solutions, and data-driven innovation across their operations to enhance how work gets done and deliver greater value to customers and patients.

Requirements

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

Nice To Haves

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.

Responsibilities

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.