Director, Quality Assurance - Regulatory

Overview

Labcorp is seeking a Director, Quality Assurance – Regulatory for our Enterprise Kit Collection Quality Management System (QMS). The role provides strategic and operational quality leadership for an enterprise‑wide specimen collection kit program supporting the lifecycle of kits used across diagnostic and clinical programs. The position reports to the Director, Regulatory Affairs and ensures compliance with FDA medical device regulations (21 CFR 820) and ISO 13485.

• 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.
• Serve 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 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.
• Evaluate, monitor, track, trend, and report metrics.
• Oversee the CAPA program, evaluating effectiveness and ensuring continuous improvement.
• 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.

• Bachelor’s degree in biology, molecular biology, biochemistry, chemistry, engineering, or related technical field.
• 15+ years of 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.

• Familiarity with laboratory‑developed tests and CAP/CLIA framework.
• 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 distill complex regulatory and quality concepts.
• Ability to influence cross‑functional teams without direct authority.
• Strong strategic thinking and problem‑solving with a high level of integrity, accountability, and commitment to quality excellence.
• Experience supporting…