About Artiva:

Artiva’s mission is to deliver highly effective, off-the-shelf, allogeneic NK cell-based therapies utilizing our Manufacturing-First approach, that are safe and accessible to cancer patients. Artiva’s pipeline includes AB-101, an ADCC enhancer NK-cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers. Artiva is currently advancing a Phase 1/2 clinical trial of AB-101 in combination with rituximab for the treatment of relapsed or refractory B-cell lymphomas. Artiva’s pipeline also includes AB-201, an anti-HER2 CAR-NK cell therapy candidate for the treatment of HER2-overexpressing tumors, such as breast, gastric, and bladder cancers, and for which an IND has been allowed by FDA, and a pipeline of CAR-NK candidates targeting both solid and hematopoietic cancers. Artiva has entered into therapeutic NK cell collaborations with Merck Sharp & Dohme Corp. and with Affimed GmbH. Artiva’s AlloNK™ platform incorporates cell expansion, activation, and engineering 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.

Job Summary:

Artiva Biotherapeutics in hiring a talnted and motivated Sr. Associate, QA Compliance – Data Integrity. This role is responsible for developing, implementing, managing, and participating in the Data Integrity Program at Artiva.

Location:

Artiva Headquarters in San Diego, CA

What you'll do:

• Evaluate manufacturing and QC equipment for data integrity gaps.
• Determine acceptable process flow maps for data acquisition, processing, and backup processes.
• Implement appropriate controls to access, modify, or delete data or audit trails.
• Develop/Exhibit expert level understanding of software, operating systems, and IT tools to ensure appropriate data integrity controls.
• Perform software administration roles as appropriate.
• Lead/support the writing of GMP procedures for data integrity (including policy, review checklists, associated IT procedures, routine verifications, and backup/restore validations).
• Implement a Scientific Data Management System, if appropriate.
• Lead/support data integrity validation planning and execution.
• Lead/support data integrity continuous improvement initiatives.
• Maintain databases and metrics.
• Track data integrity activities.
• Identify and communicate gaps; propose phase appropriate solutions.
• Support lot release activities.
• Support audits by regulatory or state agencies and partners.
• Follow applicable regulations, including FDA, ISO, ICH, and company policies and procedures.
• Support other QA department needs as identified by management.

What you will bring:

• Bachelor’s degree or a combination of relevant education and applicable job experience
• 5+ years’ experience in an FDA regulated industry and CGMP regulations.
• Must have expert level experience in a Data Integrity program.
• Ability to adapt quickly to shifting needs and/or priorities
• Able to interface well with all levels of personnel
• Proven track record of fostering a culture of collaboration and teamwork
• Strong communication skills, both verbal and written

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 cancer 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!

Artiva Biotherapeutics is an equal employment opportunity employer.

Base Salary: $92,000 - $120,000. Exact compensation may vary based on skills and experience.