Site QA Leader: Quality, Compliance & Improvement

Crown Bioscience; San Diego (CA); On-site; USD 145,000 - 170,000; Full time

Job summary

Crown Bioscience in San Diego seeks a senior QA leader to architect and drive the site-wide Quality Management System, ensuring compliance with FDA, ISO, CLIA, CAP and GCLP standards. You will build a high-performing QA team, coordinate audits, and guide CAPA processes to prevent recurrence of issues.

The role emphasizes cross-functional collaboration, data integrity, and continuous quality improvements, including readiness for client deliverables and regulatory inspections.

Qualifications

• Bachelor’s degree in a scientific discipline.
• 3+ years of preclinical/clinical laboratory experience or equivalent.
• 5+ years of direct team management experience.
• Ability to work in a vivarium facility.
• Strong written and verbal communication skills.

Responsibilities

• Oversee the Quality Management System and work closely with all site departments and functions.
• Manage a high-performing and effective site quality team.
• Promote processes that ensure data integrity, consistency, continuous improvement and compliance with quality and business requirements.
• Ensure study workflows produce high quality data and deliverables to meet and exceed client expectations.
• Prepare, host, and respond to findings for external client audits and regulatory inspections.
• Oversee CAPAs, including investigations, root cause analysis and implementation of corrective procedures and preventive actions to ensure timely resolution of issues.
• Perform internal quality and EHS audits according to site and global SOPs.
• Measure and monitor performance of site and divisional KPIs.

Skills

Data integrity

Risk assessment

Quality systems

Team leadership

Audits

Communication

Education

Bachelor’s degree in a scientific discipline

Tools

CAPA system

Document control

Calibration

Audit management

Job description

Crown Bioscience in San Diego seeks a senior QA leader to architect and drive the site-wide Quality Management System, ensuring compliance with FDA, ISO, CLIA, CAP and GCLP standards. You will build a high-performing QA team, coordinate audits, and guide CAPA processes to prevent recurrence of issues.

The role emphasizes cross-functional collaboration, data integrity, and continuous quality improvements, including readiness for client deliverables and regulatory inspections.