Job Description

Kelly Science, Engineering, Technology & Telecom provided pay range This range is provided by Kelly Science, Engineering, Technology & Telecom. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $175,000.00/yr - $200,000.00/yr Kelly Science & Clinical is seeking a Director of Quality Assurance, GLP for permanent position at leading bioanalytical organization in Pleasanton, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts. $175,000 – $200,000 annually Overview: This client specializes in bioanalytical and CMC analytical services. In this role you will be responsible for the development, management, and continuous improvement of quality systems ensuring compliance with Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), and other applicable regulatory standards for our bioanalytical GLP lab. This role reports directly to the CEO. Schedule: M-F, onsite Responsibilities: Host client and regulatory inspections, including preparing and submitting responses to findings. Audit raw data, summary tables, and reports associated with GLP and GCLP protocols to ensure compliance with regulatory requirements. Maintain inspection readiness, including preparing and managing site-specific documentation. Establish and ensure compliance with GLP, GCLP, and applicable FDA regulatory standards. Develop and manage the company’s Master Schedule. Create, administer, and maintain QA Standard Operating Procedures (SOPs), QA files, and QA audit logs. Monitor and interpret regulatory requirements to ensure alignment with business processes and procedures. Author and review SOPs and Statistical Analysis Plans (SAPs). Conduct and report inspections of internal facilities and audits of external vendors to assess compliance with regulatory standards. Establish and administer a company Risk Register. Identify and address regulatory compliance issues, providing guidance to other departments. Deliver monthly compliance status reports, highlighting issues and corrective actions. Represent the QA function in company meetings. Qualifications: Bachelor’s degree in Science required, master’s or PhD preferred. 10+ years of relevant industry experience in bioanalytical or pharmaceutical company. Subject matter expert in GLP compliance, regulations, and requirements. Seniority level Seniority level Director Employment type Employment type Full-time Job function Job function Science and Quality Assurance Referrals increase your chances of interviewing at Kelly Science, Engineering, Technology & Telecom by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Get notified about new Director of Quality Assurance jobs in San Francisco Bay Area . 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