Lab QMS Project Manager

Requirements

• Minimum of five (5) years of experience supporting laboratory operations, laboratory quality management, regulatory compliance, or laboratory project management.
• Demonstrated experience managing multiple work streams, 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 CDC 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.

Demonstrates expertise in laboratory Quality Management Systems (QMS) and regulatory compliance, with a strong ability to manage projects, coordinate cross-functional teams, and implement quality improvement initiatives. Proficient in developing project plans, tracking performance metrics, and ensuring adherence to laboratory standards and requirements.

• Laboratory Quality Management Systems (QMS)
• Regulatory Compliance
• Project Management
• Audit Processes
• Stakeholder Management

• Quality Metrics
• CAPA
• Document Control
• Risk Registers
• Quality Records
• Inspection Readiness
• Gap Assessments
• Project Trackers
• Audit Reports
• Training Records

• Problem-Solving
• Analytical Skills
• Facilitation
• Written Communication
• Verbal Communication

• ISO 17025
• ISO 15189
• ISO 9001
• CLIA
• CAP
• GLP
• FDA Quality Requirements
• CDC Laboratory Policies
• Laboratory Operations
• Quality Improvement Activities

• Microsoft Office
• Teams
• Share Point
• Excel-Based Trackers
• Power BI
• LIMS
• Electronic Document Management Systems
• Quality Workflow Systems