Manager - Quality Assurance
July 13
🏡 Remote – Anywhere in California
Description
•Reporting to the Associate Director, Quality Assurance, the Manager/Sr. Manager, Quality Assurance will assist in quality oversight and management of GxP activities internally at QED and externally with QED vendors, consultants, and service providers •Provide QA support for analytical development and commercialization •Assist in development, implementation and maintenance of analytical trending including stability •Monitor ongoing compendial updates and communicate to cross functional teams •Provide guidance, review and approve external laboratory investigations •Assist in inspection readiness activities at QED •Author and implement QA GXP standard operating procedures (SOPs) •Supports management, maintenance, and evaluation of QED’s Quality Management Systems and processes for optimization and continuous improvement •Perform internal and external document review and approval •Other duties as assigned or required
Requirements
•Bachelor's degree in a chemistry, another scientific discipline or equivalent experience •Minimum of 5 years pharmaceutical industry experience in Quality Assurance, or other relevant roles •Experience with analytical instrumentation, methods, validation, and investigations, including stability program management •Knowledge of applicable GXP regulations (e.g., CFRs and ICH) •Ability to build relationships and work collaboratively with various individuals within the department, company, and external vendors •Ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
Benefits
•Patient Days, where we hear directly from individuals living with conditions we seek to impact •A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak •An unyielding commitment to always putting patients first. Learn more about how we do this here •A de-centralized model that enables program teams to focus on advancing science and helping patients •A place where you own the vision – for your program and your own career path •A collaborative, fast-paced, data-driven environment to always perform at the top of our game •Access to learning and development resources to help you get in the best professional shape of your life •Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs) •Flexible PTO •Rapid career advancement for strong performers •Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time •Partnerships with leading institutions •Commitment to Diversity, Equity & Inclusion
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