Director of Quality Assurance

CRYSTAL PHARMATECH INC; California; On-site; USD 90,000 - 150,000; Full time

Job summary

An established industry player in the biologics analytical sector is seeking a Director of Quality Assurance to lead compliance efforts in their GLP lab. This pivotal role involves ensuring adherence to regulatory standards, hosting inspections, and mentoring QA professionals. The successful candidate will have over a decade of experience in regulatory affairs within the biotech or pharmaceutical industries, showcasing strategic thinking and strong leadership skills. Join a forward-thinking organization dedicated to supporting innovative projects from discovery to clinical development, where your expertise will drive quality and compliance excellence.

Benefits

401(k)

401(k) matching

Dental insurance

Health insurance

Paid time off

Parental leave

Wellness resources

Qualifications

• 10+ years of regulatory affairs experience in bioanalytical CRO or biotech.
• Proven leadership in compliance and quality assurance roles.

Responsibilities

• Oversee compliance with GLP and GCLP standards for the lab.
• Conduct audits and prepare for regulatory inspections.
• Develop and maintain QA Standard Operating Procedures.

Skills

Regulatory Affairs

Quality Assurance

GLP Compliance

GCLP Compliance

Leadership

Strategic Planning

Education

Bachelor’s degree in biological, chemical, or physical sciences

Master’s or Ph.D. in related fields

Job description

Benefits:

1. 401(k)
2. 401(k) matching
3. Dental insurance
4. Health insurance
5. Paid time off
6. Parental leave
7. 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

1. Host client and regulatory inspections, including preparing and submitting responses to findings.
2. Support regulatory activities across all BABM sites within the organization.
3. Audit raw data, summary tables, and reports associated with GLP and GCLP protocols to ensure compliance with regulatory requirements.
4. Maintain inspection readiness, including preparing and managing site-specific documentation.
5. Establish and ensure compliance with GLP, GCLP, and applicable FDA and international regulatory standards.
6. Develop and manage the company’s Master Schedule.
7. Create, administer, and maintain QA Standard Operating Procedures (SOPs), QA files, and QA audit logs.
8. Process, archive, and maintain QA department inspection reports and supporting documentation.
9. Monitor and interpret regulatory requirements to ensure alignment with business processes and procedures.
10. Author and review SOPs and Statistical Analysis Plans (SAPs).
11. Provide GLP and GCLP training to staff.
12. Recruit, develop, and mentor QA professionals, fostering a culture of growth and excellence.
13. Conduct and report inspections of internal facilities and audits of external vendors to assess compliance with regulatory standards.
14. Establish and administer a company Risk Register.
15. Identify and address regulatory compliance issues, providing guidance to other departments.
16. Deliver monthly compliance status reports to Test Site Management (TSM), highlighting issues and corrective actions.
17. 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.