Director, Quality Assurance - Regulatory

Labcorp is a global leader in diagnostic testing and drug development solutions, helping healthcare providers, researchers, and patients make informed decisions that advance care. Join us in our mission to improve health and improve lives.

Labcorp is looking for a Director, Quality Assurance - Regulatory, Enterprise Kit Collection Quality Management System (QMS) provides strategic and operational quality leadership for an enterprise-wide specimen collection kit program. This role 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.

Duties and Responsibilities:

List the core tasks and responsibilities associated with the role.

• Provide enterprise-wide quality governance for specimen collection kits, ensuring compliance with FDA medical device regulations and ISO 13485 across all functional areas involved in kit lifecycle activities.

• Serving as a Management Representative.

• 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.

• 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.

• Collaborate with the Director, Regulatory Affairs, Centralized Specimen Collection Kit Program, to ensure seamless integration of regulatory and quality strategies, decision-making, and governance.

• Oversee and ensure quality oversight of kit lifecycle processes including design controls, risk management, supplier qualification and oversight, manufacturing controls, labeling and IFUs, change control, complaints, CAPA, record retention, and recall readiness.

• Design and implement a complaint handling process.

• Evaluation, monitoring, tracking, trending, and metrics reporting.

• Oversee the CAPA program including evaluating, monitoring, tracking, trending and verifying effectiveness.

• 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.

• Establish, monitor, and report quality metrics and dashboards to assess QMS effectiveness, compliance status, and continuous improvement opportunities.

• Provide quality oversight of external vendors, contract manufacturers, and suppliers supporting specimen collection kits, including quality agreements, audits, performance monitoring, and issue management.

• Lead and support internal and external audits, regulatory inspections, and assessments related to specimen collection kits.

• Proactively identify, assess, and mitigate quality and compliance risks related to materials, suppliers, processes, and system changes.

• Drive a culture of quality, compliance, and continuous improvement across the enterprise kit program through coaching, influence, and collaboration (without direct people leadership).

• Serve as a quality escalation point for kit-related issues, ensuring timely investigation, root cause analysis, and implementation of effective corrective and preventive actions.

• Represent Quality Assurance as an internal consultant and strategic partner for enterprise kit-related initiatives.

• Perform other duties as assigned by management.

Minimum Education and Experience Required:

• Bachelor's degree in biology, molecular biology, biochemistry, chemistry, engineering, or related technical field required

• 15+ years experience in diagnostics, medical devices, or diagnostic laboratory services in operations, quality or regulatory, with 3+ years of direct experience in compliance related activities under 21 CFR 820 or ISO 13485