Top Quality Recruitment (TQR)
Director of Quality Assurance
Top Quality Recruitment (TQR), Oakland, California, United States, 94616
Overview
Director of Quality Assurance 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. Responsibilities
Host client and regulatory inspections, including preparing and submitting responses to findings. Support regulatory activities across all BABM sites within the organization. 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 and international 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. Process, archive, and maintain QA department inspection reports and supporting documentation. Monitor and interpret regulatory requirements to ensure alignment with business processes and procedures. Author and review SOPs and Statistical Analysis Plans (SAPs). Provide GLP and GCLP training to staff. Recruit, develop, and mentor QA professionals, fostering a culture of growth and excellence. 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 to Test Site Management (TSM), highlighting issues and corrective actions. Preferred Skills
Proven ability to provide regulatory leadership and guidance in cross-functional and matrixed environments. Strategic thinker with strong planning skills and the ability to propose innovative solutions to regulatory challenges. Education & Experience
Bachelor’s degree in biological, chemical, or physical sciences (required); advanced degrees (e.g., Master’s, Ph.D.) preferred. 10+ years of relevant regulatory affairs experience in the bioanalytical CRO or biotechnology/pharmaceutical industry, or a combination of education and experience. Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible. TQR is an equal-opportunity employer that encourages diversity. We will consider all applications. Accommodation for applicants with disabilities is available upon request. Are you looking to hire? Get started here: https://www.topqualityrecruitment.com/fill-a-position/ See hiring advice: https://www.topqualityrecruitment.com/blog/ See all available opportunities: https://www.topqualityrecruitment.com/jobs/ We thank all applicants for their interest and appreciate the time and effort involved; however, due to the large volume of resumes received only those candidates selected for an interview will be contacted. Please attach your resume to your application. Job ID: 7838
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Director of Quality Assurance 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. Responsibilities
Host client and regulatory inspections, including preparing and submitting responses to findings. Support regulatory activities across all BABM sites within the organization. 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 and international 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. Process, archive, and maintain QA department inspection reports and supporting documentation. Monitor and interpret regulatory requirements to ensure alignment with business processes and procedures. Author and review SOPs and Statistical Analysis Plans (SAPs). Provide GLP and GCLP training to staff. Recruit, develop, and mentor QA professionals, fostering a culture of growth and excellence. 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 to Test Site Management (TSM), highlighting issues and corrective actions. Preferred Skills
Proven ability to provide regulatory leadership and guidance in cross-functional and matrixed environments. Strategic thinker with strong planning skills and the ability to propose innovative solutions to regulatory challenges. Education & Experience
Bachelor’s degree in biological, chemical, or physical sciences (required); advanced degrees (e.g., Master’s, Ph.D.) preferred. 10+ years of relevant regulatory affairs experience in the bioanalytical CRO or biotechnology/pharmaceutical industry, or a combination of education and experience. Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible. TQR is an equal-opportunity employer that encourages diversity. We will consider all applications. Accommodation for applicants with disabilities is available upon request. Are you looking to hire? Get started here: https://www.topqualityrecruitment.com/fill-a-position/ See hiring advice: https://www.topqualityrecruitment.com/blog/ See all available opportunities: https://www.topqualityrecruitment.com/jobs/ We thank all applicants for their interest and appreciate the time and effort involved; however, due to the large volume of resumes received only those candidates selected for an interview will be contacted. Please attach your resume to your application. Job ID: 7838
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