Quality Assurance Manager, East Coast

Job overview

The Quality Assurance Manager, East Coast role is onsite in Princeton, NJ. The annual salary range is $120,000–$150,000. Orca Bio is a biotechnology company developing cell therapies and establishing East Coast manufacturing operations to support its clinical pipeline and future commercial availability. The manager leads site Quality Assurance and Quality Control activities to ensure manufacturing, testing, documentation, and product release meet cGMP and regulatory requirements. The role partners across manufacturing and other functions to maintain inspection readiness, support product quality, and advance production and development milestones.

What you'll do

• Lead site Quality operations, including QA Operations, Quality Systems, QC, and Compliance
• ensure compliance with cGMP, procedures, and regulatory expectations
• partner with Manufacturing and cross-functional teams
• maintain inspection readiness and continuous improvement
• oversee batch record review and product and material disposition
• lead deviation investigations, change control, CAPA, and complaint management
• oversee QC testing and laboratory investigations
• support assay transfer, validation, and qualification
• develop quality metrics and dashboards
• participate in global Quality leadership forums.

What we're looking for

Skills & competencies

full-time

quality assurance manager

east coast

princeton nj

orca bio

biotechnology

cell therapy

cgmp

quality control

regulatory compliance

$120k–$150k/year

Work arrangement

• Weekend coverage required

Benefits & perks

• Pre-IPO equity, annual bonus, medical, dental and vision benefits, paid time off, 401(k), life and accidental death and disability coverage, and parental leave.

Why this role

Leads quality operations at an East Coast cell therapy manufacturing site supporting clinical and future commercial programs.

About the employer

Orca Bio is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.