BridgeBio is hiring a
Associate Director/Director, Clinical Quality Assurance in Worldwide

Summary

BridgeBio Gene Therapy is a subsidiary of BridgeBio Pharma focused on discovering and developing drugs for patients with genetic diseases. The Associate Director/Director, Clinical Quality Assurance will define and support the quality oversight and management of GCP activities internally and externally. They will have experience in a GCP practice area, preferably in biotech/pharmaceutical sector.

Requirements

• 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

• Direct the management and maintenance of Clinical aspects of BBGT’s Quality Management System procedures and related processes for continuous improvement
• Partner with clinical study teams to coordinate appropriate and timely documentation of quality event management, including corrective action and preventive action (CAPA) plans
• 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
• 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
• Lead inspection readiness activities and provide support for audits and inspections conducted by external sources (e.g., health authorities) as applicable

Benefits

• Patient Days, where team members hear directly from individuals living with the conditions they are seeking to impact throughout the year and learn how to improve their efforts
• A culture inspired by 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 program teams to focus on advancing science and helping patients. Decision-making power is in the hands of those closest to the science
• Access to learning and development resources to help team members get in the best professional shape of their 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