Sr. Manager, QA Operations - Product Release

Role Summary

Sr. Manager, QA Operations - Product Release. Lead QA Operations activities at the company’s Contract Manufacturing Organizations (CMOs) for product release, ensuring that CMO SOPs and Master Batch Records comply with cGMPs. The role serves as the technical quality reviewer for deviations, change records, protocols, and CAPAs generated from or pertaining to Calcilytix or other BridgeBio affiliates, as needed. This hybrid role requires in-office collaboration 2-3x per week in the San Francisco office or a U.S.-based remote arrangement with quarterly or as-needed visits to the San Francisco Office. The position also involves reviewing manufacturing batch records, certificates of analysis, and certificates of compliance, and leading disposition of Drug Substance, Drug Product, and Finished Product.

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.

Qualifications

• 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.
• Prior experience in QC, Analytical Development and process validation highly desired.
• Excellent verbal and written communication skills, with a strong customer focus.
• Excellent organizational skills, ability to manage multiple tasks and competing priorities, and meticulous attention to detail.

Additional Requirements

• Travel up to 10% of total time.