# QA Operations - Drug Product, QA Manager at BridgeBio

- Company: BridgeBio
- What the company does: BridgeBio is a biotechnology company designing transformative medicines for patients with genetic diseases and cancers with clear genetic drivers. Backed by Sequoia.
- Company website: https://bridgebio.com/
- Type: Startups
- Level: Senior
- Location: San Francisco - 1800 Owens
- Work setup: On-site
- Posted: 2026-07-08
- Apply by: 2026-10-08
- Apply: https://job-boards.greenhouse.io/bridgebio/jobs/5166036007
- Page: https://www.1752.vc/careers/jobs/bridgebio-qa-operations-drug-product-qa-manager/

## About the role

Manage quality oversight at Drug Product Contract Manufacturing Organizations (CMOs). Act as QA operations lead with assigned CMOs, including review of manufacturing batch records and batch release certificates. Ensure CMO SOPs and Master Batch Records are in compliance with cGMPs and serve as technical review for deviations, change records, protocols, and CAPAs generated from or pertaining to Calcilytix or other BridgeBio affiliates, as needed.

## What they're looking for

- Bachelor's Degree in a science discipline with 8+ years of experience within a biopharmaceutical company, or contract research organization
- Strong knowledge of GMP, SOPs, Quality Systems (e.g. Lot Release, Deviation, Change Control, CAPA,) ICH and GxP principles
- Strong knowledge of FDA and other clinical trial regulations
- Prior experience in QC, Analytical Development and process validation highly desired
- Excellent verbal and written communication skills, with strong customer focus
- Excellent organizational skills, ability to manage multiple tasks and competing priorities, and maintain meticulous attention to detail

Tags: GMP QA