Associate Director, Clinical Quality Assurance

This is a fully remote position, open to applicants in California.

📋 Description

• Act as the Clinical QA lead for designated clinical programs, ensuring quality oversight during all phases of clinical development to guarantee compliance with ICH-GCP, relevant regulations, and Artiva's protocols.

• Create, implement, and execute risk-based GCP quality oversight strategies for the assigned clinical programs.

• Direct investigations into significant GCP quality and compliance incidents, evaluating their impact on subject safety and data integrity, which includes overseeing CAPA development and assessing its effectiveness.

• Organize and execute, and when necessary, manage contract auditors to perform risk-based routine and for-cause audits of clinical investigator sites, CROs, and vendors.

• Evaluate and communicate the implications of audit findings on PI/Sponsor oversight, subject safety, data integrity, adherence to protocols, and internal processes.

• Keep necessary documentation and quality records in alignment with Artiva protocols.

• Lead inspection readiness efforts for assigned programs and assist during regulatory authority inspections.

• Collaborate with internal teams and supporting functions to ensure quality compliance throughout all aspects of clinical development.

• Establish and implement a strategy for reviewing key regulatory documents linked to regulatory submissions.

• Oversee the development and execution of clinical quality procedures in partnership with Clinical Development, ensuring adherence to ICH/FDA regulations, guidelines, and expectations.

• Identify GCP compliance risks and formulate appropriate action plans in collaboration with the Clinical Department.

• Keep abreast of emerging regulations and inform the organization of relevant changes.

• Provide QA consultation and engage in risk-based sponsor oversight activities.

• Develop, support, and deliver GCP training programs for Clinical Operations staff, contributing to the overarching clinical quality training initiative.

• Establish and present quality metrics and trend analyses.

• Participate in the recruitment and hiring of Clinical Quality Assurance personnel.

⛳️ Requirements

• Bachelor of Science or Bachelor of Arts in a scientific discipline.

• Over 8 years of clinical and/or QA experience in biologics or pharmaceuticals.

• At least 4 years of experience in Clinical QA.

• Proficient knowledge and hands-on experience with regulatory inspections, audits of clinical investigator sites, vendors, and internal processes.

• Comprehensive understanding of current Good Clinical Practices and Good Clinical Laboratory Practices as they pertain to all phases of human clinical trials for cell therapy products.

• Advanced understanding of CLIA and CAP standards.

• Familiarity with ICH, GCP, GCLP, Data Privacy, and other relevant regulations and requirements in the pharmaceutical/biopharma sector.

• Solid foundation in scientific training and communication knowledge.

• Extensive knowledge of quality regulations, current industry practices, with substantial experience in interpretation and application.

• Computer proficiency in Microsoft Word, Project, and Excel programs is required.

🏝️ Benefits

• Medical, Dental, and Vision coverage.

• Group Life Insurance.

• Long Term Disability (LTD).

• 401(k) Retirement Plan.

• Employee Assistance Program (EAP).

• Flexible Spending Account (FSA).

• Paid Time Off (PTO).

• Company-paid holidays, including a week off at year-end.

• Our recognition program, Bonus.ly, allows you to exchange earned points for various rewards.