Manager, Quality Assurance - East Coast; Princeton, NJ

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Headquartered in California, Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.

With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

We are establishing manufacturing operations on the East Coast to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life‑saving therapies.

The Manager, Quality Assurance – East Coast is responsible for leading and overseeing Quality Assurance (QA) and Quality Control (QC) activities at the East coast manufacturing site. This role provides day‑to‑day quality leadership and oversight to ensure manufacturing activities, materials, testing, documentation and product release are performed in accordance with cGMP regulations, approved procedures, internal quality standards, and applicable regulatory requirements.

This manager will oversee the site QC and QA teams and serve as a key quality partner to Manufacturing, Supply Chain, MSAT and other cross functional stakeholders.

• Production Associates:
  Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color‑coded components in a GMP environment.
• Must meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for up to 3 consecutive hours at a time, minimal movement in the cleanroom, and working with or around human blood, blood‑derived materials, cells, other biological materials, and alcohol‑based sprays. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.
• Must be comfortable regularly participating in video‑based meetings.

• Provide operational leadership of the site Quality function, including QA Operations, Quality Systems, QC, and Compliance.
• Ensure site Quality activities are conducted in compliance with cGMP requirements, applicable regulatory expectations, approved procedures and Orca Bio quality standards.
• Serve as the primary site Quality partner to Manufacturing and other cross functional teams, providing timely quality guidance and escalation when needed.
• Maintain a strong state of inspection readiness and promote a culture of quality, compliance and continuous improvement.
• Oversee batch record review and disposition of products and materials, ensuring timely and compliant release.
• Lead and manage deviation investigations, change control, CAPA, and complaint management systems.
• Partner with Manufacturing, MSAT, Supply Chain, Regulatory, and R&D to support production timelines, tech transfers, and product development milestones.
• Ensure robust quality oversight of raw materials, in-process materials, and finished goods, including oversight of QC laboratory operations and testing.
• Lead and oversee QC activities supporting site manufacturing operations to ensure QC testing activities are appropriately planned and scheduled to support manufacturing and product…