Senior Director, Clinical Quality Assurance

Summary

Join BridgeBio Gene Therapy as a Sr. Director, Clinical Quality Assurance, reporting to the VP of Clinical Quality Assurance. You will define and support quality oversight and management of GCP activities internally and externally. Lead the development and maintenance of Clinical aspects of BBGT’s Quality Management System. Partner with clinical study teams and provide GCP leadership and SME. Manage direct reports and consultants. Conduct internal and external audits and reviews. The ideal candidate possesses demonstrated expertise in guiding QMS development, strong negotiation skills, and a minimum of 8 years of GCP experience. BridgeBio offers a competitive compensation and benefits package, including flexible PTO, rapid career advancement, and access to learning and development resources.

Requirements

• Demonstrated expertise in guiding development of the Quality Management System
• Ability to build relationships and work collaboratively with a variety of individuals within the department, company, and vendors
• Strong negotiation skills, flexibility, and ability to provide a solution-based approach to emerging challenges
• Ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
• Bachelor's degree in a scientific discipline or equivalent experience
• Minimum of 8 years of experience in a GCP practice area; Clinical Quality Assurance or similar role preferred
• Expertise with applicable GCP guidelines

Responsibilities

• Lead the development, management and maintenance of Clinical aspects of BBGT’s Quality Management System procedures and related processes for continuous improvement
• Lead inspection readiness activities and provide support for audits and inspections conducted by external sources (e.g., health authorities) as applicable
• Manage direct reports and consultants, as needed, in the pursuit of Clinical Quality Assurance objectives
• Partner with clinical study teams to coordinate appropriate and timely documentation of quality event management, including corrective action and preventive action (CAPA) plans, as necessary
• Provide Clinical Quality Assurance (GCP) leadership and Subject Matter Expertise (SME) to clinical study teams
• Author and maintain QA Standard Operating Procedures (SOPs). Support management of other functional area SOPs
• In collaboration with functional area leads, support training oversight
• Lead process improvement projects as needed
• Provide Clinical Quality Assurance SME to reviews of clinical protocols, amendments, Clinical Study Reports, and other clinical trial-related documents
• Plan, conduct, and/or assist in internal and external service provider audits. Review audit reports, and any corresponding corrective and preventative actions for adequacy
• Other duties as assigned or required

Preferred Qualifications

Experience with Veeva platform highly preferred

Benefits

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
• 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
• A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
• A place where you own the vision – both for your program and your own career path
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other 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