# Manager, Quality Assurance - East Coast (Princeton, NJ) at Orca Bio

- Company: Orca Bio
- What the company does: Orca Bio is helping to deliver the promise of cell therapy to patients without compromise. Backed by Lightspeed and Felicis.
- Company website: https://orcabio.com/
- Type: Startups
- Level: Senior
- Location: Princeton, NJ
- Work setup: On-site
- Pay: $120K to $150K base salary per year (USD)
- Posted: 2026-09-23
- Apply by: 2026-11-07
- Apply: https://jobs.lever.co/orcabiosystems/ab96035c-eb74-464f-b72d-5993c15129ee
- Page: https://www.1752.vc/careers/jobs/orca-bio-manager-quality-assurance-east-coast-princeton-nj/

## About the role

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.

## What they're looking for

- 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 excellent 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

Tags: Quality - Global