Lead Quality Assurance and Quality Control activities at Orca Bio's East Coast manufacturing site.
Posted by employer 2 days ago
First seen on Joblaze 2 days ago
Last verified on the company career page 15 hours ago
Not disclosed in this posting: compensation, seniority, years of experience, visa sponsorship.
Joblaze summary
The Manager of Quality Assurance at Orca Bio's East Coast manufacturing site is tasked with overseeing daily QA and QC operations to ensure compliance with regulatory standards and internal protocols. This role requires expertise in cGMP regulations and a strong background in quality management within a biotech environment. It is well-suited for a mid to senior-level professional with experience in cross-functional collaboration, particularly in manufacturing and supply chain settings. The position plays a crucial role in supporting the company's mission to deliver innovative cell therapies.
Quick facts
- Is the Manager, Quality Assurance - East Coast (Princeton, NJ) role remote?
- No — this is an on-site role in Princeton, NJ.
- Where is the role based?
- Orca Bio is hiring for this position in Princeton, NJ.
- Is this full-time or contract?
- Full-time for this Manager, Quality Assurance - East Coast (Princeton, NJ) role at Orca Bio.
From the original posting
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 overseen the site QC and QA teams and serve as a key quality partner to Manufacturing, Supply Chain, MSAT and other cross functional stakeholders.