Benefits:
401(k)
401(k) matching
Dental insurance
Health insurance
Paid time off
Parental leave
Wellness resources
Company 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 companys 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
Bachelors degree in biological, chemical, or physical sciences (required); advanced degrees (e.g., Masters, 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.
#J-18808-Ljbffr...external theft, to include ORC (Organized Retail Crime) activity. Seeks best practices and continuous improvement in all aspects of Asset Protection and safety by focusing on proactive and preventive activities that enhance profitability. What You'll be Doing:...
...HealthTrust Workforce Solutions HCA is seeking a local contract nurse RN Telemetry for a local contract nursing job in Myrtle... ...: 10/13/2025~ Duration: 13 weeks ~36 hours per week ~ Shift: 12 hours, days ~ Employment Type: Local Contract Tell us about the...
...Job Description We are seeking a hands-on Procurement Manager to lead all aspects of procurementfrom sourcing and supplier negotiation to inventory management and cost-effective purchasing. This role requires a strategic thinker who can also execute tactically. The...
About the Role If you're organized, focused, and like getting things done without a lot of noise, this role will fit you well. Were looking for someone to help us keep our data clean, accurate, and up to date. You'll handle day-to-day data entry work, check for errors...
...Primary Duties & Responsibilities Analyze tough problems and think though design challenges in a systematic way. Work under the guidance of a more senior UX designer, while still having ownership over own work. Follow an iterative design process to wireframe,...