Job Details

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 ofQuality 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

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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