Computer Software Assurance Specialist, GxP Systems

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:

The Software Assurance Specialist, GxP Systems is responsible for developing and executing validation deliverables for GxP computerized and hybrid systems used in GxP Operations (e.g., SaaS, eLMS, eQMS, Spreadsheet Validation) and ensuring computerized systems maintain a validated state throughout their lifecycle. In addition, the incumbent will act as data Integrity Lead to drive and support critical initiatives related to computerized systems quality assurance and data integrity (DI) across GxP operations.

Duties/Responsibilities:

• Develop, maintain and oversee the computer software assurance program including developing a risk management system to assess, document and implement the required validation and data integrity controls to support GxP Systems.
• Lead GxP Applicability and GAMP-5 Categorization and Criticality Impact Assessments.
• Lead Data Integrity assessments Data Integrity (DI) gap assessments to identify risks, develop remediation actions for new and existing computerized systems with a focus on end-to-end business process mapping, establishing system boundaries, system integration points, and offline/manual workflows.
• Develop and execute validation deliverables including but not limited to Validation Plans, User Requirements Specification (URS), Functional Requirements Specification (FRS), System Risk Assessment, Configuration Specifications, IQ/OQ/PQ, and Validation Summary Reports.
• Perform periodic reviews of GxP computerized systems to verify and identify requalification activities needed to maintain a validated state.
• Evaluates release notes, build instructions, and other vendor documentation to recommend and implement software and potential hardware modifications and upgrades to the system(s) using best practices in conjunction with established Change Control policies.
• Collaborate with manufacturing, quality, facilities, Quality Control and process development teams to ensure the successful implementation of qualification activities.
• Perform periodic backup, restore/retrieval testing and audit trail review to ensure the integrity of data that is backed up and/or archived.
• Support internal and audits by regulatory, state agencies and partners.
• Maintain application knowledge, including staying current on software capabilities and availability of new functionality and updates from the software vendor.
• Author and revise operating procedures and work instructions to enhance the CSA program.
• Seek out and recommend opportunities for increased CSA and data integrity program efficiencies and operational improvement through modifications to current systems, implementation of new systems and more efficient use of established systems.
• Support other QA department needs as identified by management.

Requirements/Minimum Qualifications:

• Knowledge of GxP, FDA regulations, 21 CFR Part 11, 210, and 211 and EU GMP Annex 11
• Knowledge and understanding of Gamp 5: A Risk-Based Approach to Compliant GxP Computerized Systems and FDAs Data Integrity and Compliance With CGMP Guidance for Industry
• Must be familiar with the ALCOA+ principles and their application to both electronic and paper data. Must have familiarity with GMPs, Quality, and Data Integrity principles.
• Bachelor's degree (BS or BA) in a scientific or related field
• Must have 4+ years of hands-on validation experience in FDA regulated industry
  (e.g., Cell Therapy, Pharma, or medical devices).
• Computer software assurance and/or risk-based validation experience are highly preferred.
• Strong communication skills (verbal & written) including ability to interact positively with all levels of the organization.
• Advanced Excel functions (e.g. pivot tables & charts, power query and data visualization)
• Ability to lead and implement CSA projects with minimum supervision.

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.

If all this speaks to you, come join us on our journey!

Base Salary: $110,000-125,000. Exact compensation may vary based on skills and experience.