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