Quality Assurance Manager - Laboratory

Position Overview

Key Responsibilities

• Lead and continuously improve the laboratory's Quality Management System (QMS).
• Maintain quality documentation, controlled records, SOPs, training records, and related quality systems.
• Coordinate and conduct internal audits to ensure compliance with applicable standards, accreditation requirements, laboratory procedures, and regulatory expectations.
• Support and coordinate external regulatory and accreditation audits.
• Identify nonconformances and oversee corrective and preventive actions (CAPA), root-cause investigation, follow-up, and continuous improvement initiatives.
• Manage proficiency testing schedules, reporting, documentation, and follow-up activities.
• Coordinate supplier qualification and traceability requirements.
• Maintain and archive GLP study-specific quality records.
• Review new method validations and method improvements for compliance with internal policies and regulatory requirements.
• Perform procedural audits of laboratory methods against approved SOPs and applicable regulatory requirements.
• Develop, review, and maintain Quality Management System SOPs and other controlled laboratory documentation.
• Prepare regulatory and client-facing reports, including analytical summaries, audit responses, and regulatory data packages.
• Report quality performance, audit findings, observations, nonconformances, and recommended corrective actions to laboratory leadership.
• Coordinate annual Quality Review Meetings and prepare the annual Management Review of the Quality System.
• Oversee verification and maintenance of scheduled calibration for laboratory support equipment.
• Conduct quality assurance and regulatory training for laboratory personnel.
• Communicate regulatory updates, quality concerns, operational changes, and improvement initiatives across laboratory teams.
• Provide QA-related support for client inquiries when needed.
• Supervise QA support personnel, including training, work assignments, performance management, and development.