Lab Quality Management Specialist (QMS) Project Manager
Atlanta GA
We are seeking an experienced Lab Quality Management Specialist (QMS) Project Manager to join our client team in support of a public health project. The Lab QMS Project Manager will provide project leadership, coordination, and oversight for laboratory quality management activities that support the implementation, maintenance, monitoring, and continuous improvement of laboratory quality systems.
The successful candidate will combine strong project management discipline with laboratory quality management experience. This role involves coordinating project plans, schedules, risks, deliverables, stakeholder communications, quality metrics, audit readiness activities, CAPA tracking, validation/verification documentation, training coordination, document control, and continuous improvement initiatives. The LQMS Project Manager works closely with laboratory leadership, quality managers, scientists, safety professionals, regulatory stakeholders, and clients to support compliant, reliable, and efficient laboratory operations.
This is a hybrid remote position that will require some onsite work in Atlanta, Georgia.
Responsibilities
· Project Management and Delivery: Develop and maintain project plans, schedules, milestones, risk registers, action item trackers, status reports, and deliverable matrices for LQMS-related activities. Monitor project performance and ensure project deliverables and milestones are met.
· Stakeholder Coordination: Serve as a key coordinator among laboratory leadership, client representatives, quality managers, scientific staff, safety personnel, regulatory stakeholders, vendors, and contractor team members to align expectations, resolve issues, and maintain project momentum.
· Laboratory Quality Management System (LQMS) Support: Coordinate activities that support implementation, maintenance, monitoring, and improvement of laboratory QMS/LQMS processes, including quality plans, SOPs, quality records, assessments, management review inputs, and quality objectives.
· Regulatory Compliance and Accreditation Readiness: Support compliance activities associated with applicable laboratory standards and requirements such as ISO 17025, ISO 15189, ISO 9001, CLIA, CAP, GLP, FDA quality requirements, policies, and other program-specific expectations.
· Audit and Assessment Management: Plan, coordinate, and track internal audits, external assessments, gap analyses, inspection readiness activities, audit evidence collection, deficiency tracking, and corrective action follow-up.
· Validation and Verification Coordination: Coordinate review and tracking of validation plans, verification packages, method performance documentation, technical modifications, validation summary reports, reagent stability reviews, and other laboratory quality deliverables.
· CAPA and Nonconformance Management: Track nonconforming events, feedback, complaints, root cause analyses, corrective actions, preventive actions, effectiveness checks, and trend reports to support timely resolution and sustained process improvement.
· Document Control and Records Management: Coordinate SOP development, document review cycles, controlled document publication, records retention, eBinder management, quality records, training records, and electronic document management activities.
· Quality Metrics and Reporting: Develop and maintain quality indicators, dashboards, audit findings trackers, CAPA trackers, validation status trackers, project performance metrics, and executive-level reports for laboratory leadership and client stakeholders.
· Training and Competency Tracking: Support development, scheduling, tracking, and reporting of laboratory quality training, competency assessments, onboarding resources, job aids, and role-based training requirements.
· Risk Management and Continuous Improvement: Identify project risks, dependencies, resource constraints, process gaps, and recurring quality concerns. Recommend mitigation strategies and support continuous improvement initiatives that improve laboratory efficiency, compliance, data integrity, and operational reliability.
Requirements
Required Skills and Experience
· Minimum of five (5) years of experience supporting laboratory operations, laboratory quality management, regulatory compliance, or laboratory project management.
· Demonstrated experience managing multiple workstreams, deliverables, stakeholders, and deadlines in a regulated laboratory or scientific environment.
· Strong knowledge of laboratory QMS/LQMS principles, quality systems, quality records, audit readiness, CAPA, document control, training records, equipment records, and quality metrics.
· Working knowledge of applicable standards and frameworks such as ISO 17025, ISO 15189, ISO 9001, CLIA, CAP, GLP, FDA quality requirements, CLSI guidance, and laboratory policies.
· Experience with audit processes, regulatory compliance, gap assessments, inspection readiness, corrective action follow-up, and quality improvement activities.
· Experience developing project trackers, dashboards, executive reports, quality management review inputs, audit reports, risk registers, and corrective action status updates.
· Excellent problem-solving, analytical, facilitation, written communication, verbal communication, and stakeholder management skills.
· Ability to translate laboratory quality requirements into actionable project plans and coordinate cross-functional teams to successful completion.
· Proficiency with Microsoft Office, Teams, SharePoint, Excel-based trackers, Power BI or dashboard tools, LIMS, electronic document management systems, and quality workflow systems preferred.
· Superior customer interface skills with emphasis on client communications, timely follow-up, documentation accuracy, and professional collaboration.
· Ability to obtain necessary immunizations, including Hepatitis B, MMR, Tdap/Tetanus, IPV/Polio (as applicable), and Meningococcal, among others, as required for the work environment.
· Ability to obtain government clearance.
· Must be legally authorized to work in the United States without the need for employer sponsorship, now or at any time in the future.
Education and Training
· Bachelor’s degree in Medical Laboratory Science, Biology, Microbiology, Chemistry, Biochemistry, Public Health, Quality Management, Project Management, or a related scientific discipline.
· Advanced degree or formal training in laboratory quality management, regulatory science, or project management is preferred.
· Project Management ProfesLaboratory Quality Management System sional (PMP), Certified Associate in Project Management (CAPM), Lean Six Sigma, ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), ISO 9001 or ISO 17025 auditor training, CLSI Laboratory Quality Management System certificate, or equivalent certification is preferred.
· Medical Technologist, Medical Laboratory Scientist, ASCP, AMT, AAB, or equivalent laboratory certification is a plus when applicable to the laboratory environment.
· Biosafety Level 2 (BSL-2) training preferred; BSL-3 training is desirable when applicable to the assigned laboratory environment.
· Tier 1 select agent clearance is preferred when applicable to assigned work.
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