Job Description

Crystal Bio Solutions , a member of Crystal Pharmatech, is a leading biologics analytical organization with operations in the San Francisco Bay Area and New Jersey. We specialize in bioanalytical and CMC analytical services for biotech and pharmaceutical companies developing biologics. Our expertise spans a wide range of therapeutic modalities, supporting projects from discovery through clinical development.

Role Description

Reporting directly to the CEO, the Director of Quality Assurance (QA) 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 in Pleasanton, California. This role ensures that facilities, equipment, personnel, and procedures meet all regulatory requirements and effectively supports nonclinical and clinical testing activities.

Key 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 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.
• 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.

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