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:

This position is responsible for Quality Assurance Compliance activities at Artiva with key responsibilities including deviations, CAPA, supplier qualification, lot release, change control, data integrity, and internal / external audits.

Location:

Artiva Headquarters in San Diego, CA

What you'll do:

• Lead/support the Deviation and CAPA / SCAR systems by investigating, reviewing, assessing, tracking, follow-up, and completing all quality events.
• Perform Batch Record reviews for Artiva’s products.
• Interact with CMOs and the Artiva Manufacturing Department to resolve issues related to the review of batch records and deviations.
• Implement and perform Lot Release for all Artiva manufactured products.
• Manage the Data Integrity program.
• Manage and maintain the Supplier Qualification program by ensuring all supplier files are up to date and all qualification activities are performed.
• Lead/support the Change Control program by reviewing, assessing, tracking, follow-up, and completing all change control documentation.
• Manage the Internal and External Audit program and ensure that audit schedules are executed according to plan.
• Perform external / internal audits as needed.
• Maintain databases and metrics.
• Identify and communicate compliance gaps; propose phase appropriate solutions.
• Track the status of Deviations, CAPAs, Change Controls, Audits, and Lot Releases.
• 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.
• Supervise Quality Assurance personnel as required.

What you will bring:

• Bachelor’s degree in a scientific field.
• 10+ years’ experience in an FDA regulated industry and expert knowledge of CGMP regulations.
• 4+ years of supervisory experience.
• Experience in aseptic manufacturing.
• Strong problem solving, influencing and negotiation skills.
• Ability to work independently and in a team setting.
• Prior experience working with electronic document management systems is a plus.

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: $120K- $170K. Exact compensation may vary based on skills and experience.