Manager/ Director of Quality Assurance
Full Time • Crystal Bio Solutions - BABM
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 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.
« The salary range represents the anticipated base pay for this position. Actual compensation may vary based on factors including, but not limited to, skills, qualifications, experience, education, and location.
« As part of our recruitment process, we may use technology-assisted tools to support application review and improve efficiency. All hiring decisions are made by our team.
« Crystal Bio Solutions is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, or any other protected status in accordance with applicable laws.
Compensation: $120,000.00 - $180,000.00 per year
About Us
Crystal Pharmatech, established in 2010, is a global company with approximately 300 employees and three R&D centers located in Suzhou (China), New Jersey, San Francisco (USA), and Toronto (Canada). Our key differentiator is our integrated and specialized services, including API solid-state research, crystallization, preformulation, formulation development and manufacturing, clinical supply.
Our Company
Crystal Pharmatech, established in 2010, is a global company with approximately 300 employees and three R&D centers located in Suzhou (China), New Jersey, San Francisco (USA), and Toronto (Canada). Our key differentiator is our integrated and specialized services, including API solid-state research, crystallization, preformulation, formulation development and manufacturing, clinical supply.
Our Company
Crystal Pharmatech, established in 2010, is a global company with approximately 300 employees and three R&D centers located in Suzhou (China), New Jersey, San Francisco (USA), and Toronto (Canada). Our key differentiator is our integrated and specialized services, including API solid-state research, crystallization, preformulation, formulation development and manufacturing, clinical supply.
With an average of 20 years of experience, our scientific leadership team has successfully delivered over 100 early phase and 19 commercialized products for global pharmaceutical companies. We have served over 1,000 clients, supporting more than 2,000 new chemical entities.
Leveraging our unique expertise, we collaborate with you to design and develop the most suitable crystal form and formulation for further development. Our guiding principle of "getting the crystal form and formulation right the first time for Phase I" not only expedites the progression of your molecule to IND filing and Phase I clinical trials, but also minimizes the necessity for human PK bridging studies. This approach saves valuable time and reduces costs as your program moves forward to Phase II or subsequent clinical trials.
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