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. The Senior Manager, Clinical QA will lead GCP oversight across clinical programs, driving audits and ensuring compliance to protect patient safety and data integrity.
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
Skills
- 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
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