Senior Associate, QA Compliance

Artiva Biotherapeutics•San Diego, CA

2d•Onsite

About The Position

Artiva is a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, creates an opportunity to generate potentially transformative therapies. This position is responsible for Quality Assurance Compliance activities supporting deviations, CAPAs, change control, and product releases.

Requirements

Bachelor’s degree or a combination of relevant education and applicable job experience
5+ years’ experience in an FDA regulated industry and CGMP regulations.

Nice To Haves

Late-phase to commercial phase experience a plus.
Cell Therapy experience a plus.

Responsibilities

Support the deviation and CAPA/SCAR Systems by investigating, reviewing, assessing, tracking, follow-up, and completing all quality events.
Support the Change Control program by reviewing, assessing, tracking, follow-up, and completing all change control documentation.
Maintain databases and metrics.
Identify and communicate compliance gaps; propose phase appropriate solutions.
Track the status of Deviations, CAPAs, and Change Controls.
Perform internal and/or external audits, as needed.
Support product releases by reviewing batch records.
Support risk assessment 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.