Note: The job is a remote job and is open to candidates in USA. Artiva Biotherapeutics is a clinical-stage biotechnology company focused on developing NK cell-based therapies. They are seeking an Associate Director, Clinical Quality Assurance to lead quality oversight for clinical programs, ensuring compliance with regulations and overseeing audits and training.
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
Skills
- 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
- 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
Benefits
- 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.
Company Overview
Company H1B Sponsorship