Manager, Quality Operations

🔥 1 minute ago

🎸 Tennessee – Remote

🎸 Tennessee – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

⚙️ Operations

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LabConnect

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2002

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

💰 $24.5M Series A - LabConnect on 2017-06

Healthcare • Pharmaceuticals • Biotechnology

LabConnect is a global central laboratory solutions partner that provides technology-driven, customized, orchestrated, and scalable laboratory and data services to support clinical trials and drug development worldwide. Its offerings include central and specialty bioanalytical testing, radiopharmaceutical support, decentralized/near-home collection, custom collection kits and high-volume kitting, companion diagnostics and assay validation, data management and harmonization, regulatory and scientific project management, and commercial/post-market support. LabConnect serves sponsors and CROs across multiple therapeutic areas (oncology, vaccines, cell and gene therapy/ATMPs and more), emphasizing program oversight and operational execution for clinical research.

📋 Description

• Ensure quality, timeliness, and regulatory compliance of operations within a central laboratory supporting clinical trials • Oversee implementation and maintenance of the Quality Management System (QMS) • Manage the Quality Event and CAPA program • Ensure adherence to GCP and applicable regulatory standards • Facilitate sponsor, regulatory, and internal audit programs • Guide business groups, subject matter experts, vendors, and management in issue management, impact assessment, root cause analysis, CAPA, effectiveness checks, and training • Champion quality initiatives aligned with CLIA, CAP, GCP, ICH, FDA, and EMA standards • Assess 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 • Support vendor quality issue resolution, CAPA follow-up, and effectiveness checks • Prepare for and facilitate sponsor audits, regulatory inspections, and internal audits • Coordinate 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 facilitate quality improvement initiatives • Monitor and report quality KPIs • Provide leadership updates and contribute to strategic quality planning • Prepare QMS training materials and conduct training • Collaborate with Human Resources on QMS-related training requirements • Perform other tasks defined by Quality Assurance Leadership

🎯 Requirements

• Bachelor’s degree in life sciences, medical technology, or related field • Minimum 4 years of experience in a central lab or clinical trial lab environment • At least 2 years in a quality management role, or an equivalent combination of education and experience • Strong understanding of the CFRs, CLIA, CAP checklists, GCP, and ICH guidelines as they pertain to clinical trial operations • Strong understanding of clinical laboratory and clinical trials environments • Excellent communication, leadership, analytical, organizational, and interpersonal skills • Ability to independently manage responsibilities and apply deep subject matter expertise to solve complex problems and guide decision making • Ability to read, analyze, and interpret technical procedures, professional journals, and governmental regulations, and write reports, business correspondence, and procedures • Ability to present information and respond to questions from managers, clients, and auditors • Ability to apply basic algebra and statistics to quality data and trend analysis • Ability to solve practical problems and interpret written, oral, diagram, 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 preferred

🏖️ Benefits

• Fully remote role • Minimal travel • Professional quality certifications are optional

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