Quality Assurance Manager

Quality Assurance Manager

San Diego, California, United States

Quality Assurance Manager

The primary responsibility of this position is to oversee GxP activities and maintain the effective quality system within the company. This position will report directly to CEO and work closely with our CMC and Clinical Operations teams to ensure the compliance of relevant regulatory. The duties include but not limited to maintain appropriate document system, review/approve critical documents and perform the audit internally or externally.

Main Job Tasks and Responsibilities

• Responsible for QAU administration.
• The maintenance of the document management system.
• Identify training needs and organize training interventions to meet quality standards
• Perform the internal/external audit and finalize the audit report
• Evaluate audit findings and ensure appropriate corrective as well as preventive actions in place if applicable
• Cooperate with internal team/external parties to investigate customer complaints and non-conformance issues
• Analyze data to identify areas for improvement in the quality system
• Additional duties as required and assigned

Must Have

• B.S. or M.S. in sciences
• Prior experience as a QA Auditor
• Auditing experience of GMP quality standards
• Ability to analyze and sort problems in a logical way with root cause analyses of non-compliance and CAPA

Nice-to-Have

• Working experience with CMO/CRO/Outsourcing Testing Lab (OTL)
• Drug substance/product or pharmaceutical industry-specific experience
• Certifications an advantage including Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma
• Auditing experience of GCP quality standards
• Experience with implementation of corrective/preventive action programs
• Knowledge of relevant regulatory requirements (FDA GxP regulations and ICH guidelines)

Key Competencies

• attention to detail
• communication skills - verbal and written
• data collection, management and analysis
• problem analysis and problem solving
• planning and organizing
• judgment
• decision-making
• teamwork