What are the responsibilities and job description for the Director of Quality Assurance Operations position at Crystal Bio Solutions, a member of Crystal Pharmatech?
Job Title : Director of Quality Assurance Operations
Company Description
Crystal Bio Solutions , a member of Crystal Pharmatech, is a prominent biologics analytical organization based in the San Francisco Bay Area and New Jersey. We are dedicated to providing exceptional bioanalytical and CMC analytical services for biotech and pharmaceutical companies focused on biologics development. Our expertise covers a wide range of therapeutic modalities, supporting projects from early discovery through clinical development.
Role Description
The Director of Quality Assurance Operations will report directly to the CEO and will play a pivotal role in shaping and enhancing our quality systems. This position ensures our bioanalytical GLP lab, located in Pleasanton, California, remains compliant with Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), and other applicable regulatory standards. The Director will ensure that our facilities, equipment, personnel, and procedures meet or exceed all regulatory requirements to support both nonclinical and clinical testing activities effectively.
Key Responsibilities
- Lead client and regulatory inspections, preparing necessary documentation and responses to findings.
- Support regulatory initiatives across all BABM sites within the organization.
- Audit raw data, summary tables, and reports related to GLP and GCLP protocols for regulatory compliance.
- Maintain inspection readiness by managing site-specific documentation effectively.
- Develop and enforce compliance with GLP, GCLP, and all applicable FDA and international regulatory standards.
- Create and manage a comprehensive company Master Schedule.
- Establish, administer, and maintain QA Standard Operating Procedures (SOPs) and related documentation.
- Process, archive, and maintain QA department inspection reports and supporting documents.
- Monitor and interpret regulatory requirements to ensure business alignment.
- Author and review SOPs and Statistical Analysis Plans (SAPs).
- Deliver GLP and GCLP training programs for staff development.
- Recruit, mentor, and develop QA professionals to foster a culture of excellence.
- Conduct comprehensive inspections of internal facilities and audits of external vendors for compliance assessment.
- Establish and maintain a company Risk Register.
- Identify and address regulatory compliance concerns while guiding other departments.
- Compile and deliver monthly compliance status reports to Test Site Management (TSM), outlining issues and corrective actions.
- Represent the QA function in various company meetings.
Qualifications
Location : Pleasanton, California
