QA Operations - Drug Product, QA Manager

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on

In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.

Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'llask"why not?" and help reengineer the future of biopharma. At Bridge Bio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.

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 Bridge Bio affiliates, as needed.

• 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 Product
• 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

This role requires in-office collaboration 2-3x per week in our San Francisco office.

• 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
• Travel up to 10% total time

$150,000 — $175,000 USD

At Bridge Bio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process.

Bridge Bio is a multi-state employer, and this salary range may not…