Sr. Manager, Clinical Quality Assurance

Artiva Biotherapeutics•San Diego, CA

3d•Onsite

About The Position

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.

Requirements

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.

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.