What are the responsibilities and job description for the GMP Auditor, QA Compliance position at Artiva Biotherapeutics?
About Artiva:
Artiva is clinical-stage, publicly-traded biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artiva’s lead program, AlloNK®, is an allogeneic, off-the-shelf, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is delivered in the outpatient setting with no required hospitalization.
AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjögren’s Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artiva’s pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers.
Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cell’s NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California.
For more information, visit www.artivabio.com.
Job Summary:
This position is responsible for cGMP auditing and supplier management activities at Artiva.
Duties/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.
Requirements:
- 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
- Certified Quality Auditor credential is a plus.
- 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
Why you should apply:
We have a fantastic team and philosophy! We are passionate – we deeply care about our team, our science, and improving the lives of patients. We are tenacious – laser-focused on our mission and undeterred in our commitment to deliver life-saving medicines for cancer patients. We are innovative - pushing into new frontiers for patient benefit. We are transparent - believers in flat, accessible, and open communication paths. We are inclusive – committed to the diversity of our team and ensuring that all voices are heard.
In addition to a great culture, we offer:
· A beautiful facility
· An entrepreneurial, highly collaborative, and innovative environment
· Comprehensive benefits, including:
- 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.
If all this speaks to you, come join us on our journey!
Base Salary: $100,000 - 120,000. Exact compensation may vary based on skills and experience.