Director, Quality Assurance

Posted today

crown bioscienceSan Diego (CA)

Quality Control Systems Managers Research and Development in Biotechnology (except Nanobiotechnology)

SENIORITY

Manager

SALARY

$145,000 - $170,000 per year

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About the role

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Job 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 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 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 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

Minimum Requirements:

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.

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