QUALITY ASSURANCE MANAGER (PHARMACEUTICAL COMPOUNDING)

Join a leading compounding pharmacy committed to patient-specific solutions and pharmaceutical excellence. This role leads QA operations to ensure compliance, safety, and continuous improvement across all departments.

REQUIREMENTS

• Bachelor’s degree in a Science or Business-related field
• Minimum of 10 years’ experience in quality, regulatory affairs, and pharmaceutical compounding
• Must have hands-on knowledge of 503A and 503B regulations
• Strong leadership, analytical, and organizational skills
• Proficient in Microsoft Office and QA tracking tools
• Familiarity with PCAB, ACHC, URAC, HIPAA, and OSHA standards

• Lead and manage the quality assurance team and processes across the organization
• Develop, implement, and audit QA protocols to ensure compliance with internal and regulatory standards
• Monitor quality trends and implement corrective actions based on data and root cause analysis
• Oversee product testing, inspection, and documentation procedures
• Investigate non-conformance reports and customer complaints, ensuring resolution and process improvement
• Conduct internal audits and prepare for external inspections
• Collaborate with cross-functional teams to integrate quality into all workflows
• Train QA staff and support professional development