Quality Assurance Lead

Job Summary

We are seeking a Technical Lead for Quality Assurance to oversee compliance operations within our specialized Chemical, Biological, Radiological, Nuclear, and Energetics (CBRNE) laboratory services business. This role involves directing quality training, managing internal and external audits, coordinating team assignments, and maintaining transparent communications with the Quality Manager. The successful candidate will guide QA personnel and independently evaluate whether laboratory workflows and deliverables fully conform to strict government regulations, client specifications, and corporate quality management policies.

Key Responsibilities

• Corrective Action Management: Review areas of noncompliance to establish effective remediation pathways. Personally implement standard corrective actions or deliver advanced recommendations to executive leadership for highly complex, multi-layered issues.
• Root Cause & Prevention: Facilitate intensive causal analyses to identify foundational vulnerabilities. Design, execute, and track comprehensive corrective and preventive action (CAPA) plans while verifying long-term mitigation effectiveness.
• Proposal & Cost Estimating: Collaborate with corporate leadership to develop research proposals, ensuring a precise understanding of stakeholder requirements and operational risks. Generate detailed quality assurance cost estimates for all upcoming project pipelines.
• Process Improvement: Identify vulnerabilities or gaps within existing quality management system (QMS) controls. Drive continuous process engineering and optimization to consistently meet and exceed rigorous compliance metrics.
• Policy Development: Partner with management to architect robust quality assurance guidelines and standard operating procedures (SOPs) that accurately align with evolving industry regulations and corporate objectives.
• Program Execution: Establish and deploy tactical quality assurance plans inside an active analytical laboratory environment, using data-driven metrics and management controls to secure error-free project execution and delivery.
• Team Leadership & Mentorship: Provide professional mentorship and performance goals to junior QA staff. Design, update, and facilitate specialized corporate quality assurance training frameworks.
• Operational Coordination: Coordinate with Quality Management to assign new laboratory studies to auditors, balancing individual workloads and ensuring site inspections are finalized on schedule. Oversee project team budgets, conduct equipment and system validation audits, perform internal facility checks, and run rigorous peer reviews of completed audits.
• Audit & Inspection Leadership: Provide tactical direction to auditors and execute routine, non-routine, or highly focused internal quality assurance inspections. Serve as a key organizational representative during audits conducted by external clients or federal regulatory agencies.
• Subcontractor & Operation Oversight: Audit on-site subcontracted services to verify absolute adherence to experimental designs. Review live project operations, author formal reports documenting inspection findings for senior management, and ensure all tracked issues reach a validated resolution.

Core Qualifications

• Education: Bachelor’s degree in a relevant scientific or technical discipline.
• Experience: Minimum of 8 years of progressive experience administering quality assurance initiatives inside an active laboratory environment, including hands-on familiarity with analytical instrumentation and proven personnel leadership capabilities.
• Standards Expertise: Demonstrated experience working directly under ISO 17025 guidelines.
• Regulatory Knowledge: Robust working knowledge of federal laboratory regulations, compliance protocols, and standard industry guidance documents.
• Security Requirement: Must possess the ability to successfully obtain and maintain a Top Secret security clearance.

Preferred Qualifications

• Certifications: Active credentialing as a certified auditor (such as ASQ Certified Quality Auditor (CQA), ISO 9001:2015 Lead Auditor, or an equivalent professional designation).
• Committee Involvement: Past experience serving on internal or external technical committees to provide a strategic quality and compliance perspective for continuous improvement goals.
• Program Breadth: Direct experience supporting a diverse portfolio of overlapping quality, safety, and laboratory compliance frameworks.