Job Summary:
This is an exciting opportunity to join Artiva as we continue expanding our impact in cell therapy. As Senior Manager, Clinical QA, you'll lead risk-based GCP oversight across our clinical programs - driving audits, investigations, and inspection readiness that protect patients and data integrity from first-in-human through approval. You'll represent Clinical QA on study teams, collaborating closely with all development functional areas to embed quality into every stage of the program.

Essential Duties & Responsibilities:
• Serve as the Clinical QA lead for assigned clinical programs and provide quality oversight across all phases of clinical development to ensure compliance with ICH-GCP, applicable regulations, and Artiva's procedures.
• Implement and conduct risk-based GCP quality oversight strategies for assigned clinical programs.
• Conduct investigations of clinical investigator site issues, GCP quality issue investigations, determine root cause, corrective and preventive actions, and ensure appropriate and adequate documentation.
• Plan, conduct/manage contract auditors, and oversee risk-based routine and for-cause audits of investigator sites, CROs, vendors, processes.
• Assess and communicate the impact of audit findings on PI/Sponsor oversight, subject safety, data integrity, and business operations.
• Maintain required documentation and quality records in accordance with Artiva procedures.
• Support inspection readiness activities and participate in regulatory health authority inspections and inspection response activities.
• Interact with internal teams and supporting functions to ensure quality compliance across all aspects of clinical development.
• Represent Clinical QA on study teams and work collaboratively with all development functional areas.
• Review key company documents associated with INDs, protocols, Investigator Brochure(s) and other relevant clinical trial documents for compliance with applicable regulations.
• Implement a strategy to provide a review of key regulatory documents associated with regulatory submissions.
• Identify GCP compliance risks and develop appropriate courses of action in partnership with the Clinical Department.
• Maintain awareness of emerging regulations, guidance documents, and best industry practices and communicate relevant changes to management.
• Provide QA consultation and participate in risk-based sponsor oversight activities.
• Support and deliver GCP training for Clinical Operations staff, contributing to the broader clinical quality training program.
• Present quality metrics and trend analyses.

Education and Experience:

• BS or BA in a scientific field.
• 6+ years of clinical and/or QA experience in biologics or pharma.
• 3+ years of Clinical QA experience.
• Knowledge and hands on experience in regulatory inspections, clinical investigator site/vendor/internal audits
• Thorough knowledge of current Good Clinical Practices as they relate to all phases of cell therapy product human clinical trials.
• Expert level of understanding of CLIA, CLIP, CAP.
• Knowledge of ICH, GCP, GCLP, Data Privacy and other applicable regulations and requirements in the pharmaceutical/biopharma industry.
• Sound basis of scientific (Training/Communications) knowledge.
• Expert knowledge of quality regulations, current industry practices, and strong experience with interpretation and application.
• Computer skills required to operate Microsoft Word, Project, and Excel programs.

In addition to a great culture, we offer:

• A beautiful facility
• An entrepreneurial, highly collaborative, and innovative environment
• Comprehensive benefits, including:

• Medical, Dental, and Vision
• 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 the year-end holiday week
• Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.

Base Salary: $ 150,000 - $172,000. Exact compensation may vary based on level, skills and experience.