Manager, Quality Control

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. 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 investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

We have built a state‑of‑the‑art, 100,000‑square‑foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) 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 Control is responsible for providing oversight for the GMP testing of cell therapy products and critical intermediates. Additionally, this role will support regulatory and internal inspections and oversee key aspects of quality control workflows, including leading investigations of out‑of‑specification results and addressing environmental monitoring excursions. This position will work cross‑functionally to ensure that products are sampled and tested under applicable regulations and guidelines of current Good Manufacturing Practices (cGMPs).

There are regular interactions with internal manufacturing and with service providers. The successful candidate shall be an experienced manager with a proven track record, who can operate in a multidisciplinary, collaborative, fast paced environment.

• Lead GMP testing operations and meet critical business goals.
• Oversee day‑to‑day operations associated with raw material testing, in‑process testing, and release and stability testing of clinical and commercial cell therapy products. Perform data reviews and release completed test results. Provide oversight for microbiology testing and environmental monitoring.
• Plan, forecast, and allocate laboratory resources and equipment to ensure efficient execution of quality control testing, including managing staffing levels, scheduling workflows, maintaining instrument availability, and coordinating procurement and maintenance to meet project timelines and regulatory requirements.
• Provide supervision of QC associates; assess, plan and manage resource allocations for QC; define training requirements and manage training status of QC staff as required to execute activities of the function; schedule QC and EM projects and schedules.
• Hire, mentor and develop QC personnel, including QC Supervisors.
• Contribute to the design, implementation and continuous improvement of Quality Control systems that are technically sound, promote effective and efficient operations, comply with cGMP requirements and meet commercial stage standards. Review and approve test methods and procedures associated with QC activities.
• Provide leadership support during trouble shooting of assay performance and equipment as it relates to ensuring the quality and compliance of the product.
• Collaborate with analytical development on updates and validation of test methods. Define method trending metrics and perform method trending.
• Identify and mitigate risks in QC labs that could negatively impact the safety, identity, strength purity or quality of the product.
• Define requirements and lead equipment qualification, maintenance and calibration practices and manage instrument capacity.
• Participate in outsourcing decisions and oversight of contract testing organizations for specific tests as needed.
• Contribute and lead direct interactions with Regulatory agencies (audits, etc.).
• Responsible for generating environmental monitoring reports and managing the environmental monitoring program for the site.

• 7+ years of relevant experience in quality control, or a related field such as analytical development or quality…