Director, Quality Assurance - Regulatory

Job description

Labcorp is a leader in diagnostics, drug development and healthcare innovation. Across every role, we harness data and AI to work smarter, move faster and create breakthrough solutions that improve health outcomes for people. With our global scale and deep expertise, you'll do meaningful work, grow your career and make a real impact. Together, we're improving health and improving lives. 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 Preferred Qualifications: • 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, andHigh level of integrity, accountability, and commitment to quality excellence • Experience supporting inspections and audits as medical device manufacturer or specification developer • Experience in working closely with Regulatory Affairs in medical device environment The position ensures alignment with FDA medical device regulations (21 CFR 820) and ISO 13485 requirements and partners closely with the Director, Regulatory Affairs, Centralized Specimen Collection Kit Program. Together, these roles provide complementary regulatory and quality oversight to ensure consistent, compliant, and efficient kit development, sourcing, manufacturing, distribution, and post-market activities across the organization. Pay Range: $130,000 - $150,000 annually 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. LBP Only Eligible Positions: 20% LBP 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. 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. For more detailed information, please click here . Labcorp is proud to be an Equal Opportunity Employer: Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. We encourage all to apply If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement .