Artiva Biotherapeutics · 2 hours ago
GMP Auditor, QA Compliance
Artiva Biotherapeutics is a clinical-stage biotechnology company focused on developing NK cell-based therapies for autoimmune diseases and cancers. The GMP Auditor will be responsible for conducting cGMP audits and managing supplier activities to ensure compliance with regulatory standards.
BiotechnologyLife ScienceTherapeutics
Responsibilities
Perform GMP/GDP audits in accordance with the external and internal audit program
Support GXP audits (GLP, GCP, GCLP), as necessary
Perform Drop-In GMP Internal audits
Create and maintain audit schedules
Track audit responses to completion
Oversee and maintain the supplier qualification program
Support the creation and execution of Quality Agreements with suppliers
Update databases, prepare metrics, identify and communicate trending and tracking of audits and related supplier management activities
Support audits by regulatory or state agencies and partners
Support QA review of Analytical Development and Process Development data and reports, as needed
Follow applicable regulations, including FDA, ISO, ICH, company policies and procedures
Support other QA department needs as identified by management
Qualification
Required
Bachelor's degree or a combination of relevant education and applicable job experience
5+ years' experience in an FDA regulated industry and expert knowledge of CGMP regulations
Ability to adapt quickly to shifting needs and/or priorities
Able to interface well with all levels of personnel
Excellent communications skills, both written and verbal and a high degree of professionalism
Exceptional attention to detail
Flexibility to travel
Preferred
Certified Quality Auditor credential is a plus
Benefits
Medical, Dental, and Vision
Group Life Insurance
Long Term Disability (LTD)
401(k) Retirement Plan with match
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
Artiva Biotherapeutics
Artiva Biotherapeutics is a biotech company focused on developing and commercializing allogeneic natural killer (NK) cell therapies.
H1B Sponsorship
Artiva Biotherapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Public CompanyTotal Funding
$198MKey Investors
Venrock Healthcare Capital Partners
2024-07-18IPO
2021-02-26Series B· $120M
2020-06-26Series A· $78M
Leadership Team
Recent News
2025-12-16
2025-11-15
2025-11-15
Company data provided by crunchbase