Senior QA Leader - Global Quality & Compliance

Crown Bioscience, Inc.; San Diego (CA); Hybrid; USD 120,000 - 140,000; Full time

Job summary

Crown Bioscience, Inc. is seeking a Quality Assurance professional to lead the site-wide quality management program, ensuring compliance with applicable laws and global programs. You will drive continuous improvement, support QA systems, and respond to quality breaks with corrective actions to prevent recurrence.

Responsibilities include hosting external audits, coordinating CAPA actions, and monitoring KPIs while collaborating across departments to meet client expectations and corporate goals.

Qualifications

• Requires a Bachelor's degree in a scientific discipline.
• Minimum 5 years of related quality assurance experience.
• Experience with CAP/CLIA is required.
• Ability to write clear internal communications and reports.

Responsibilities

• Provide focus for the Quality Management System and promote compliance.
• Prepare, host, and respond to findings for external audits (regulatory, ISO/CAP/CLIA).
• Prepare non-conformance reports and monitor performance and trends.
• Identify root causes and implement corrective actions and preventive measures.
• Perform internal audits as required and drive continuous improvement.
• Oversee supplier/vendor management for quality program compliance.
• Support site EHS program and global QMS improvements.

Skills

Quality Assurance

Auditing

CAPA

Regulatory knowledge

Communication

Cross-functional collaboration

Education

Bachelor’s degree in a scientific discipline

Tools

Microsoft Office

Job description

Crown Bioscience, Inc. is seeking a Quality Assurance professional to lead the site-wide quality management program, ensuring compliance with applicable laws and global programs. You will drive continuous improvement, support QA systems, and respond to quality breaks with corrective actions to prevent recurrence.

Responsibilities include hosting external audits, coordinating CAPA actions, and monitoring KPIs while collaborating across departments to meet client expectations and corporate goals.