Associate Director, Clinical Quality Assurance

Artiva Biotherapeutics•San Diego, CA

13d•$172,000 - $195,000

About The Position

Artiva is seeking an Associate Director, Clinical Quality Assurance to serve as the Clinical QA lead for assigned clinical programs and provide quality oversight across all phases of clinical development. In this role, you will design and execute risk-based GCP quality oversight strategies, lead investigations of significant compliance events, and plan and conduct routine and for-cause audits of clinical investigator sites, CROs, and vendors. You will drive inspection readiness, support regulatory authority inspections, and partner with Clinical Development to build and implement clinical quality procedures that ensure compliance with ICH-GCP, applicable FDA regulations, and Artiva’s procedures. The ideal candidate will also deliver GCP training, define and present quality metrics and trend analyses, and help identify and mitigate compliance risks across the organization. This is a highly visible role in which you will have a voice and direct influence with leadership, helping shape quality strategy and decisions that impact subject safety and data integrity.

Requirements

BS or BA in a scientific field.
8+ years of clinical and/or QA experience in biologics or pharma.
4+ 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 and Good Clinical Laboratory Practices as they relate to all phases of cell therapy product human clinical trials.
Expert level of understanding of CLIA and 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.

Nice To Haves

Experience in small or emerging biotechnology companies.
Familiarity with global pharmacovigilance regulations and quality systems.
Experience supporting or overseeing GVP quality activities, safety vendors, or pharmacovigilance processes.
Demonstrated understanding of the interface between GCP and GVP requirements, including management of safety-related quality events and inspection readiness activities.

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.
Develop, implement and conduct risk-based GCP quality oversight strategies for assigned clinical programs.
Lead investigations of significant GCP quality and compliance events, assessing the impact to subject safety and data integrity, including oversight of CAPA development and effectiveness.
Plan, conduct, and when applicable manage contract auditors, to oversee risk-based routine and for-cause audits of clinical investigator sites, CROs, vendors.
Assess and communicate the impact of audit findings on PI/Sponsor oversight, subject safety, data integrity, protocol compliance, and internal processes.
Maintain required documentation and quality records in accordance with Artiva procedures.
Lead inspection readiness activities for assigned programs and support regulatory authority inspections.
Interact with internal teams and supporting functions to ensure quality compliance across all aspects of clinical development.
Define and implement a strategy to provide a review of key regulatory documents associated with regulatory submissions.
Lead development and implementation of clinical quality procedures in collaboration with Clinical Development, ensuring compliance with ICH/FDA regulations, guidelines, and expectations.
Identify GCP compliance risks and develop appropriate courses of action in partnership with the Clinical Department.
Monitor emerging regulations and communicate relevant changes to the organization.
Provide QA consultation and participate in risk-based sponsor oversight activities.
Define, support and deliver GCP training for Clinical Operations staff, contributing to the broader clinical quality training program.
Define and present quality metrics and trend analyses.
Participate in interviewing and hiring Clinical Quality Assurance staff.