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Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies for blood cancer patients, aiming to improve survival rates and reduce risks associated with traditional allogeneic stem cell transplants. The company is establishing manufacturing operations on the East Coast to ensure consistent and reliable delivery of high-precision cell therapy products.
The Manager, Quality Assurance – East Coast will lead and oversee Quality Assurance and Quality Control activities at the East Coast manufacturing site. This role provides day-to-day quality leadership to ensure manufacturing activities, materials, testing, documentation, and product release comply with cGMP regulations, approved procedures, internal quality standards, and applicable regulatory requirements. The 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.
Key responsibilities include:
- Provide operational leadership of the site Quality function, including QA Operations, Quality Systems, QC, and Compliance
- Ensure site Quality activities comply with cGMP requirements, regulatory expectations, approved procedures, and Orca Bio quality standards
- Serve as the primary site Quality partner to Manufacturing and cross-functional teams, providing timely quality guidance and escalation
- Maintain 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 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 QC laboratory operations
- Lead QC activities supporting site manufacturing operations with appropriate planning and scheduling
- Provide oversight of laboratory investigations, atypical results, out-of-specification results, and other QC-related events
- Support assay transfer, validation, qualification, and implementation activities
- Develop and implement site quality metrics and dashboards to monitor performance and drive continuous improvement
- Participate in global Quality leadership forums to align site practices with corporate standards and strategy
Requirements:
- Bachelor's degree in a scientific or engineering discipline required; advanced degree (MS, PhD, PharmD) preferred
- 7+ years of experience in pharmaceutical or biotech manufacturing quality, with at least 5 years in a leadership role or proven excellence in role
- Strong background in cGMP regulations and clinical manufacturing (Phase I–III); experience with biologics, cell & gene therapies, or sterile manufacturing is highly desirable
- 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
- Experience managing regulatory inspections and building compliant quality systems from the ground up is a plus
- Strong interpersonal skills and the ability to influence at all levels of the organization
