Quality Compliance Lab Manager

Buffalo Grove, IL Target Salary Range: $140,000-$150,000/year + Bonus Position Summary The Quality Compliance Lab Manager is responsible for leading a regulated laboratory environment supporting medical device testing, with a strong focus on blood-based assays for product performance, accuracy, and quality control. This role ensures laboratory operations meet FDA and global regulatory requirements, maintains data integrity, and drives high standards of scientific rigor and compliance. The manager provides both technical and people leadership, ensuring the laboratory operates efficiently, remains inspection-ready, and delivers reliable analytical results that support product quality and patient safety. Key Responsibilities Laboratory Leadership & Operations Lead day-to-day operations of the analytical laboratory, including testing associated with product verification, validation, and quality control Ensure accurate, timely, and compliant execution of laboratory testing, including blood-based and biochemical assays Review and approve analytical data, reports, and test results to support quality decisions Establish priorities, allocate resources, and ensure alignment with organizational needs Regulatory Compliance & Quality Systems Ensure laboratory compliance with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and applicable laboratory standards Author, review, and maintain SOPs, test methods, and validation protocols Maintain a constant state of inspection readiness and support FDA, notified body, and internal audits Lead or support investigations including OOS/OOT, deviations, nonconformances, CAPA, and change control Ensure adherence to data integrity principles (ALCOA+) across all laboratory activities Analytical Methods & Equipment Oversee development, validation, and lifecycle management of analytical methods, particularly those involving biological samples Ensure laboratory equipment is qualified, calibrated, and properly maintained Manage introduction of new technologies and continuous improvement of laboratory capabilities Coordinate with external laboratories when needed People Management & Development Lead, develop, and mentor laboratory staff including analysts and technicians Ensure proper training, qualification, and ongoing competency of all personnel Promote a culture of quality, accountability, and scientific excellence Safety & Environmental Compliance Ensure compliance with laboratory safety standards, including handling of biological materials and chemical hygiene requirements Promote safe work practices and address any safety concerns or incidents Continuous Improvement & Cross-Functional Support Drive continuous improvement initiatives related to laboratory efficiency, compliance, and data quality Collaborate with Quality, R&D, Regulatory Affairs, and other functions to resolve technical and quality issues Support validation activities, product development, and technology transfer efforts as needed Required Qualifications Bachelor’s degree in Chemistry, Biochemistry, Biology, Biomedical Engineering, or a related scientific discipline 5-7+ years of experience in an analytical or clinical laboratory environment within medical device, diagnostics, or pharmaceutical industries At least 2 years of leadership experience (people or technical leadership) Hands-on experience with laboratory techniques involving biological samples (e.g., blood-based assays) Strong working knowledge of FDA regulations and quality systems Preferred Qualifications Advanced degree in a scientific discipline Experience supporting FDA inspections or regulatory audits Familiarity with LIMS or other laboratory data systems Experience in FDA remediation or compliance improvement initiatives (nice to have, not required) Exposure to manufacturing environments (nice to have, not required) Lean, Six Sigma, or formal root cause analysis training Key Competencies Strong leadership and team development skills Deep understanding of laboratory operations and analytical testing Commitment to data integrity and regulatory compliance Excellent problem-solving and decision-making abilities Strong written and verbal communication skills Ability to manage multiple priorities in a fast-paced, regulated environment Working Conditions Combination of laboratory and office environment Work with biological materials, including blood samples Occasional off-hours support may b