Manager, Quality Operations

This is a fully remote position, open to applicants in Tennessee.

📋 Description

• Ensure the quality, punctuality, and regulatory compliance of operations within a central laboratory that supports clinical trials.

• Supervise the implementation and upkeep of the Quality Management System (QMS).

• Oversee the Quality Event and CAPA program.

• Guarantee adherence to GCP and relevant regulatory standards.

• Facilitate sponsor, regulatory, and internal audit initiatives.

• Guide business groups, subject matter experts, vendors, and management in issue management, impact assessment, root cause analysis, CAPA, effectiveness checks, and training.

• Advocate for quality initiatives aligned with CLIA, CAP, GCP, ICH, FDA, and EMA standards.

• Evaluate and report compliance with clinical trial protocols, sponsor requirements, and regulatory guidelines.

• Manage Quality Events from issue identification through investigation, containment, root cause analysis, correction, CAPA implementation, and effectiveness monitoring.

• Coordinate cross-functional Quality Event resources, meetings, timelines, and deliverables.

• Assist in vendor quality issue resolution, CAPA follow-up, and effectiveness checks.

• Prepare for and facilitate sponsor audits, regulatory inspections, and internal audits.

• Coordinate the resolution of audit findings and CAPAs.

• Collaborate with lab operations, data management, project teams, and others on sample handling, testing, and reporting quality.

• Review method validations, equipment qualifications, and laboratory investigations.

• Analyze quality monitoring data and apply statistical techniques to identify causes of non-conformances.

• Perform trend analysis and CAPA effectiveness measures.

• Identify process inefficiencies and promote quality improvement initiatives.

• Monitor and report on quality KPIs.

• Provide leadership updates and contribute to strategic quality planning.

• Prepare QMS training materials and conduct training sessions.

• Collaborate with Human Resources regarding QMS-related training requirements.

• Execute other tasks as defined by Quality Assurance Leadership.

⛳️ Requirements

• Bachelor’s degree in life sciences, medical technology, or a related field.

• A minimum of 4 years of experience in a central lab or clinical trial lab setting.

• At least 2 years in a quality management position, or an equivalent combination of education and experience.

• Strong understanding of the CFRs, CLIA, CAP checklists, GCP, and ICH guidelines related to clinical trial operations.

• Solid understanding of clinical laboratory and clinical trials environments.

• Exceptional communication, leadership, analytical, organizational, and interpersonal skills.

• Ability to independently manage responsibilities and utilize deep subject matter expertise to resolve complex problems and guide decision-making.

• Capability to read, analyze, and interpret technical procedures, professional journals, and governmental regulations, as well as write reports, business correspondence, and procedures.

• Proficiency in presenting information and addressing queries from managers, clients, and auditors.

• Ability to apply basic algebra and statistics to quality data and trend analysis.

• Skill in solving practical problems and interpreting written, oral, diagrammatic, or schedule instructions.

• Working knowledge of Microsoft Office applications, including Word, Excel, PowerPoint, and Project.

• Experience with eQMS (e.g., Veeva), eLMS, document control, and other industry software is preferred.

🏝️ Benefits

• Fully remote role.

• Minimal travel required.

• Professional quality certifications are optional.