Director, Quality Assurane

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

This position will be responsible to lead and oversee the site wide quality management program designed to ensure continuous measurement and improvement in site compliance and performance. This includes building a high-performing and highly effective QA team, implementing key global initiatives at the site level, and ensuring the integrity and consistency of site operations and client deliverables. The position will employ effective tools to support risk assessment and mitigation of quality issues and to address and resolve quality events by implementing measures to correct and prevent future occurrences. The position will also be responsible for ensuring compliance to applicable laws, guidelines and regulation governing the site's operations. The success of the role will be measured by, but is not limited to, continuous improvement of site operational quality and compliance, efficiency of operational workflows, meeting or exceeding client expectation and corporate goals and objectives.

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
• Prepare non conformance reports and monitor reporting performance and trends
• 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
• Perform risk and impact assessments of site processes, procedures and QEs
• Measure and monitor performance of site and divisional KPIs
• Report site quality metrics and identify improvement opportunities
• Actively contribute to the success of the overall QA team and the site
• Responsible for ensuring the company and its quality management system (QMS) meets relevant regulations and standards (e.g., FDA, ISO standards, CLIA, CAP, GCLP, GDP, EH&S) and other guidelines.
• Oversee supplier/vendor management, assuring that vendors are operating in compliance with the applicable quality program and regulations guidelines.
• Managed QA department and quality activities such as document control, training, calibration, complaints, incoming inspection, non-conformance, deviation, CAPA system, supplier management system, internal and external audits.
• Actively participate and/or drive Global QMS improvements as required
• Support global sustainability program and related activities
• Requires a Bachelor’s degree in a scientific discipline
• Requires 3+ years of relevant preclinical and/or clinical laboratory experience or equivalent
• Requires 5+ years of direct team management experience
• Willing and able to work in a facility with a vivarium
• Able to make competent decisions based on a review of various types of data and situations
• Able to write clear, coherent internal and external business communications
• Ability to work across teams by being an effective team player with strong communication and interpersonal skills.
• Have exceptional organizational, multi-tasking and time-management skills.
• Able to communicate and interact externally and internally across all levels of the organization with a high degree of professionalism and diplomacy.

Preferred Requirements

• Experience with ISO 9001, CAP/CLIA and/or GCLP in the life sciences industry is preferred
• Experience working with EHS teams is preferred

Salary range is $145,000-170,000

This salary (or salary range) is merely an estimate and may vary based on an applicant’s skills and prior relevant experience.

Crown Bioscience is committed to a diverse and inclusive workplace. Crown Bioscience is an equal opportunity employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.