Quality Manager

Job Description

<h3>Job Description</h3><p>Job Description<p><strong>About the Opportunity</strong><p>A growing manufacturer in the health product industry is looking for a <strong>Quality Manager</strong> to lead its Quality Assurance and Quality Control functions. This is a hands-on leadership role focused on maintaining regulatory compliance, product safety, and continuous improvement in a fast-paced, GMP-compliant environment.</p><hr /><strong>Key Responsibilities</strong><p><strong>Leadership & Team Development</strong></p><ul><li><p>Lead and mentor a QA/QC team, fostering a culture of accountability and continuous improvement</p></li><li><p>Serve as the site lead during audits, inspections, and client interactions</p></li><li><p>Track and report on quality KPIs and site scorecard metrics</p></li></ul><p><strong>Quality Assurance (QA)</strong></p><ul><li><p>Oversee and maintain the Quality Management System (QMS)</p></li><li><p>Ensure compliance with GMP, HACCP, and FDA 21 CFR Part 111 regulations</p></li><li><p>Manage internal audits, supplier qualification, deviations, CAPAs, and change controls</p></li><li><p>Approve validation protocols and quality documentation</p></li></ul><p><strong>Quality Control (QC)</strong></p><ul><li><p>Supervise testing of raw materials, in-process checks, and finished goods</p></li><li><p>Manage environmental and microbial monitoring programs</p></li><li><p>Review and approve lab data, Certificates of Analysis (COAs), and results</p></li><li><p>Collaborate with R&D and production during product scale-up and validation</p></li></ul><p><strong>Training & Compliance</strong></p><ul><li><p>Develop and manage GMP training programs</p></li><li><p>Ensure training records are updated and regulatory standards are met</p></li><li><p>Support and respond to regulatory and third-party audits</p></li></ul><p><strong>Continuous Improvement</strong></p><ul><li><p>Lead root cause analysis and implement <span >corrective/preventive</span> actions</p></li><li><p>Analyze trends to drive proactive quality improvements</p></li><li><p>Provide regular reports and quality metrics to senior leadership</p></li></ul><hr /><strong>Qualifications</strong><ul><li><p>Previous experience in a quality management or senior QA/QC role</p></li><li><p>Strong working knowledge of GMP, HACCP, FDA 21 CFR Part 111, and QMS tools</p></li><li><p>Demonstrated success leading audits and ensuring regulatory compliance</p></li><li><p>Excellent communication, leadership, and analytical skills</p></li></ul><hr /><strong>What the Client Offers</strong><ul><li><p>A dynamic work environment with purpose-driven products</p></li><li><p>Opportunities for growth in a rapidly expanding sector</p></li><li><p>Competitive salary package based on experience and qualifications</p></li></ul></p></p>