Senior Manager, Clinical Quality Assurance

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

📋 Description

• Act as the Clinical QA leader for designated clinical programs, providing quality oversight throughout all phases of clinical development to ensure adherence to ICH-GCP, relevant regulations, and Artiva’s protocols.

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

• Investigate issues at clinical investigator sites, conduct GCP quality investigations, identify root causes, propose corrective and preventive actions, and guarantee proper documentation.

• Plan, manage contract auditors, and supervise risk-based routine and for-cause audits of investigator sites, CROs, vendors, and processes.

• Evaluate and communicate the implications of audit findings on PI/Sponsor oversight, subject safety, data integrity, and business operations.

• Ensure maintenance of necessary documentation and quality records per Artiva procedures.

• Assist with inspection readiness activities and engage in regulatory health authority inspections and response tasks.

• Collaborate with internal teams and support functions to ensure quality compliance in all areas of clinical development.

• Serve as the Clinical QA representative on study teams, working cooperatively with all functional areas of development.

• Review essential company documents related to INDs, protocols, Investigator Brochure(s), and other pertinent clinical trial documents for compliance with applicable regulations.

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

• Identify GCP compliance risks and create suitable action plans in partnership with the Clinical Department.

• Stay informed about emerging regulations, guidance documents, and best industry practices, and relay relevant changes to management.

• Offer QA consultation and take part in risk-based sponsor oversight activities.

• Facilitate and provide GCP training for Clinical Operations staff, contributing to the wider clinical quality training program.

• Present quality metrics and trend analyses.

⛳️ Requirements

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

• Over 6 years of clinical and/or QA experience in biologics or pharmaceuticals.

• A minimum of 3 years of experience in Clinical QA.

• Proficient knowledge and hands-on experience with regulatory inspections, clinical investigator site/vendor/internal audits.

• Comprehensive understanding of current Good Clinical Practices relating to all phases of cell therapy product human clinical trials.

• Expert-level knowledge of CLIA, CLIP, CAP.

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

• Strong foundational knowledge in scientific training and communications.

• In-depth expertise in quality regulations, current industry practices, and substantial experience with interpretation and application.

• Proficient computer skills, including Microsoft Word, Project, and Excel.

🏝️ Benefits

• Medical, Dental, and Vision coverage.

• Group Life Insurance.

• Long Term Disability (LTD) insurance.

• 401(k) Retirement Plan.

• Employee Assistance Program (EAP).

• Flexible Spending Account (FSA).

• Paid Time Off (PTO).

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

• Our recognition program, Bonus.ly, allows you to exchange earned points for desired items.