BridgeBio · 4 hours ago
Sr. Manager, QA Operations - Product Release
San Francisco - 1800 Owens
Full-time
Hybrid
Senior Level, Lead/Staff
$160K/yr - $186K/yr
8+ years expBridgeBio is a pioneering biopharmaceutical company focused on developing life-changing medicines for patients with unmet needs. The Sr. Manager, QA Operations - Product Release will manage lot release activities at CMOs, ensuring compliance with cGMPs and acting as the technical quality reviewer for various quality processes and documentation.
BiotechnologyHealth CareLife ScienceMedicalPharmaceutical
Responsibilities
Represent QA Operations on internal and external project teams, audits and inspections, and participate in monitoring of CMO performance
Review and manage master and executed manufacturing batch records from CMOs, including release activities, and related documents such as specifications, analytical and microbiological methods, stability study/protocols, process and method validation protocols and reports
Author and perform quality review of SOPs and quality events (deviations/investigations, OOSs/OOTs, change controls, supplier notifications, etc.)
Lead disposition of Drug Substance (DS), Drug Product (DP) and Finished Product (FP)
Communicate/escalate manufacturing deficiencies/non-conformances to management, present issues during escalation, and work with CMOs to ensure timely resolution
Support review of regulatory filings
Support audit of CMOs
Qualification
Required
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
General knowledge of FDA and other global clinical trial regulations
Excellent verbal and written communication skills, with a strong customer focus
Excellent organizational skills, ability to manage multiple tasks and competing priorities, and maintain meticulous attention to detail
Travel up to 10% total time
Preferred
Prior experience in QC, Analytical Development and process validation highly desired
Benefits
401K with 100% employer match on first 3% & 50% on the next 2%
Employee stock purchase program
Pre-tax commuter benefits
Referral program with $2,500 award for hired referrals
Comprehensive health care with 100% premiums covered - no cost to you and dependents
Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
Hybrid work model - employees have the autonomy in where and how they do their work
Unlimited flexible paid time off - take the time that you need
Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
Flex spending accounts & company-provided group term life & disability
Subsidized lunch via Forkable on days worked from our office
We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
Company
BridgeBio
BridgeBio focuses on the development and commercialization of precision medicines for various genetic diseases and cancers.
201-500 employees
H1B Sponsorship
BridgeBio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
2023 (4)
2022 (4)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$4.9BKey Investors
Blue OwlQatar Investment AuthorityKohlberg Kravis Roberts
2026-01-16Post Ipo Debt· $550M
2025-02-25Post Ipo Debt· $500M
2024-03-04Post Ipo Equity· $250M
Leadership Team
Justin To
CEO, Skeletal Dysplasias (QED Therapeutics)
Neil Kumar
CEO and Founder
Recent News
BioWorld Financial Watch
2026-01-17
Company data provided by crunchbase