What are the responsibilities and job description for the Senior Good Clinical Practice (GCP) Auditor position at Artiva Biotherapeutics?
About Artiva:
Artiva is clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers.
Artiva’s lead product candidate, AlloNK, is a non-genetically modified, off-the-shelf, allogeneic, cryopreserved NK cell therapy designed to enhance the antibody-dependent cellular cytotoxicity (ADCC) effect of mAbs to drive B-cell depletion and to be administered in the community setting. Unlike CAR-T and any genetically modified cell therapy, AlloNK is a non-genetically modified NK cell therapy candidate and has not shown any secondary malignancies in our clinical trials, which is a benefit in an autoimmunity setting. Using the company’s proprietary cell therapy manufacturing platform, Artiva can generate thousands of doses of cryopreserved, infusion-ready AlloNK cells from a single cord blood unit. The FDA has granted Fast Track designation to AlloNK in combination with rituximab or obinutuzumab for the treatment of class III or IV lupus nephritis, and AlloNK in combination with rituximab for the treatment of relapsed or refractory non-Hodgkin lymphoma of B-cell origin (B-NHL).
AlloNK, is currently being evaluated in combination with B-cell targeted mAbs in
patients with autoimmune diseases and cancers, such as lupus nephritis, SLE, rheumatoid arthritis, pemphigus vulgaris, the ANCA-associated vasculitis subtypes GPA/MPA, and B-NHL. In addition, we are also pursuing AlloNK and our CAR-NK product candidates in multiple indications through collaborator-funded trials. Artiva’s cell therapy manufacturing platform incorporates cell expansion and activation technology developed by Artiva’s strategic partner, GC Cell Corporation, a member of the GC family of companies, a leading healthcare company in Korea.
Artiva is headquartered in San Diego and backed by leading venture investors including 5AM Ventures, RA Capital Management and venBio Partners.
For more information, visit www.artivabio.com.
Job Summary:
This position is responsible for managing the GCP audit schedule, performing audits, writing audit reports, and reviewing and tracking audit responses to completion at Artiva.
Responsibilities:
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:
Base Salary: $125,000 - 145,000. Exact compensation may vary based on skills and experience.
Artiva is clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers.
Artiva’s lead product candidate, AlloNK, is a non-genetically modified, off-the-shelf, allogeneic, cryopreserved NK cell therapy designed to enhance the antibody-dependent cellular cytotoxicity (ADCC) effect of mAbs to drive B-cell depletion and to be administered in the community setting. Unlike CAR-T and any genetically modified cell therapy, AlloNK is a non-genetically modified NK cell therapy candidate and has not shown any secondary malignancies in our clinical trials, which is a benefit in an autoimmunity setting. Using the company’s proprietary cell therapy manufacturing platform, Artiva can generate thousands of doses of cryopreserved, infusion-ready AlloNK cells from a single cord blood unit. The FDA has granted Fast Track designation to AlloNK in combination with rituximab or obinutuzumab for the treatment of class III or IV lupus nephritis, and AlloNK in combination with rituximab for the treatment of relapsed or refractory non-Hodgkin lymphoma of B-cell origin (B-NHL).
AlloNK, is currently being evaluated in combination with B-cell targeted mAbs in
patients with autoimmune diseases and cancers, such as lupus nephritis, SLE, rheumatoid arthritis, pemphigus vulgaris, the ANCA-associated vasculitis subtypes GPA/MPA, and B-NHL. In addition, we are also pursuing AlloNK and our CAR-NK product candidates in multiple indications through collaborator-funded trials. Artiva’s cell therapy manufacturing platform incorporates cell expansion and activation technology developed by Artiva’s strategic partner, GC Cell Corporation, a member of the GC family of companies, a leading healthcare company in Korea.
Artiva is headquartered in San Diego and backed by leading venture investors including 5AM Ventures, RA Capital Management and venBio Partners.
For more information, visit www.artivabio.com.
Job Summary:
This position is responsible for managing the GCP audit schedule, performing audits, writing audit reports, and reviewing and tracking audit responses to completion at Artiva.
Responsibilities:
- Independently perform GCP audits in accordance with internal and external GCP audit program.
- Lead the preparation, conduct, and reporting of routine and non-routine GCP audits including clinical investigator sites, Clinical Service Providers (CSPs), and internal processes/systems.
- During the GCP audits, identify potential issues and risks with impact on clinical trials or specific processes. Ensures adequate debriefing and communication of these issues and risks.
- Escalate critical issues (i.e., events of potential serious GCP noncompliance or clinical trial participant safety) and schedule and support meetings, if applicable.
- Present information logically and concisely, both verbally and in the writing of issued GCP audit reports within the required timelines. May provide advice and consultation on GCP quality issues during GCP audit activities.
- Develop, create, and maintain GCP audit schedules.
- Manage the appropriateness of GCP audit responses, the suitability of Corrective and Preventive Actions (CAPAs), and oversee the delivery of CAPA actions arising from GCP audits. Review and track GCP audit responses to completion.
- Oversee and maintain the GCP CSP’s qualifications and activities.
- Support the creation and execution of Quality Agreements with GCP CSPs.
- Update trackers/databases, prepare metrics, identify and communicate trending and tracking of GCP audits, and related GCP CSP management activities.
- Support GCP audits by regulatory or state agencies and partners.
- Create and support revisions of GCP audit Standard Operating Procedures (SOPs), Work Instructions (WIs), forms, and templates.
- Identify and communicate gaps; propose phase-appropriate solutions.
- Support audits by regulatory or state agencies and partners.
- Follow applicable regulations, including United States (US) FDA, GCP, guidelines, and company policies and procedures.
- Support other QA department needs as identified by management.
- Bachelor’s degree or a combination of relevant education and applicable job experience.
- 5-10 years of experience in a US and/or ex-US regulated industry.
- Extensive knowledge of GCP guidelines and other relevant US and ex-US regulatory requirements.
- Experience conducting audits of CSP (vendor) and clinical investigator sites
- The Certified Clinical GCP Auditor credential is a plus.
- Ability to quickly adapt to shifting needs and/or priorities.
- Able to interface well with all levels of personnel, especially with CSPs and clinical investigator site staff.
- Excellent attention to detail.
- Exceptional communication and interpersonal skills, with a proven ability to lead and collaborate in a cross-functional team environment.
- Flexibility to travel domestically and internationally extensively (50%).
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
- 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.
Base Salary: $125,000 - 145,000. Exact compensation may vary based on skills and experience.
Salary : $125,000 - $145,000
