Quality Assurance Manager

Kelly® Science & Clinical is seeking a Quality Assurance Manager for a Direct Hire 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.

Salary:

$120k – $165k 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 the bioanalytical GLP lab.

Schedule:

Monday-Friday, standard working hours

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.
• 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.