Quality Assurance Manager

Systimmune

12 hours ago

Redmond, WA

Onsite

Full Time

Senior

0 applicants

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About this role

A Quality Assurance Manager at SystImmune supports the Translational Science department by ensuring compliance with Bioanalytical Lab QA (GLP/FDA) and CLIA/CAP requirements. The role involves leading FDA inspection readiness, managing quality systems, and partnering with scientific teams to maintain quality standards across clinical pathology and bioanalytical operations.

Skills

Qualifications

Bachelor’s or Master’s degree in Life Sciences or related field7+ years of QA experience in bioanalytical (GLP/FDA) and/or CLIA/CAP laboratory environmentsStrong knowledge of QMS processes (CAPA, deviation, change control, document control)Experience supporting or leading FDA inspections for bioanalytical labsExperience supporting laboratory audits and inspections

About Systimmune

systimmune.com

SystImmune is a Redmond, WA–based biopharmaceutical company developing bi‑specific and multi‑specific antibodies and antibody‑drug conjugates (ADCs) to treat cancer. Its mission is to create biologics that both directly attack tumors and activate the immune system to enhance anti‑tumor responses, using proprietary protein‑engineering and antibody‑discovery platforms. A multidisciplinary team across the U.S. and China focuses on rapid, cost‑efficient clinical development. SystImmune is a member of the Biokin Pharmaceutical group and partners with Bristol Myers Squibb and OrbiMed, and it is seeking additional collaborators to develop and commercialize its therapies worldwide.