About the role
structured by ORIManager, Quality Assurance - East Coast (Princeton, NJ)Princeton, NJQuality – Quality - Global /Regular, Full-Time Employee /On-siteapply for this job 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,…
What you will do
- 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.
What they are looking for
- Bachelor’s degree in a scientific or engineering discipline required
- 7+ years of experience in pharmaceutical or biotech manufacturing quality, with at least 5 years in a leadership role or proven excellent in role.
- Strong background in cGMP regulations and clinical manufacturing (Phase I–III)
- Deep knowledge of GMP and global regulatory standards (FDA, EMA, ICH, etc.).
- Proven ability to lead cross-functional teams in a dynamic, fast-paced clinical environment.
- Excellent problem-solving, communication, and decision-making skills.
- Strong interpersonal skills and the ability to influence at all levels of the organization.
Nice to have
- advanced degree (MS, PhD, PharmD) preferred.
- experience with biologics, cell & gene therapies, or sterile manufacturing is highly desirable.
- Experience managing regulatory inspections and building compliant quality systems from the ground up is a plus.
Benefits
- pre-IPO equity
- annual bonus
- medical, dental, and vision benefits
- PTO
- 401(k) plan
Full posting text
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.