Director, Quality Assurance

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

Job summary

Crown Bioscience in San Diego, CA seeks a Site Quality Leader to oversee the Quality Management System and drive continuous improvement across operations and client deliverables. You will build a high-performing QA team, manage audits, CAPAs, and risk assessments while ensuring compliance with FDA, ISO and CLIA standards, and collaborating across functions to sustain data integrity and quality outcomes.

This role requires strong leadership and strategic communication to align with corporate

Qualifications

• Bachelor’s degree in a scientific discipline.
• 3+ years preclinical and/or clinical laboratory experience.
• 5+ years direct team management experience.
• Strong knowledge of quality systems and regulatory standards.

Responsibilities

• Oversee the Quality Management System and work with all site departments.
• Manage a high-performing site QA team.
• Promote data integrity and continuous improvement.

Skills

Quality Management

Team Leadership

Regulatory Compliance

Audits

CAPA

Data Integrity

Risk Assessment

QMS

Stakeholder Communication

Analytical Skills

Education

Bachelor’s degree in a scientific discipline

Tools

QMS software

Job description

Grow Your Career Where Talent Meets InnovationJob Summary: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 functionsManage a high-performing and effective site quality teamPromote processes that ensure data integrity, consistency, continuous improvement and compliance with quality and business requirementsEnsure study workflows produce high quality data and deliverables to meet and exceed client expectationsPrepare, host, and respond to findings for external client audits and regulatory inspectionsPrepare non conformance reports and monitor reporting performance and trendsOversee CAPAs, including investigations, root cause analysis and implementation of corrective procedures and preventive actions to ensure timely resolution of issuesPerform internal quality and EHS audits according to site and global SOPsPerform risk and impact assessments of site processes, procedures and QEsMeasure and monitor performance of site and divisional KPIsReport site quality metrics and identify improvement opportunitiesActively contribute to the success of the overall QA team and the siteResponsible 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 requiredSupport global sustainability program and related activitiesMinimum Requirements:Requires a Bachelor’s degree in a scientific disciplineRequires 3+ years of relevant preclinical and/or clinical laboratory experience or equivalentRequires 5+ years of direct team management experienceWilling and able to work in a facility with a vivariumAble to make competent decisions based on a review of various types of data and situationsAble to write clear, coherent internal and external business communicationsAbility 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 preferredExperience working with EHS teams is preferredSalary range is $145,000-170,000This 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.