BridgeBio is hiring a
Senior Director Clinical Quality Assurance, Remote - United States

Summary

The job is for a Senior Director of Clinical Quality Assurance at QED Therapeutics, an affiliate of BridgeBio Pharma. The role involves driving process improvement, regulatory authority inspection readiness, audits, SOP development, CAPA management, quality metrics and reporting, and other duties as assigned. The ideal candidate should have a Bachelor's degree in a scientific discipline or equivalent experience, minimum of 8 years of experience in a GCP practice area, and expertise with applicable GCP guidelines.

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
• A strong team player with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs
• 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

Responsibilities

• Drive strategy and execution of process improvement
• Lead (or support) mock inspections, identify potential compliance gaps, and implement corrective actions as needed
• Lead internal audits and external audits, as deemed necessary
• Develop, review, and revise SOPs to ensure alignment with regulatory standards and industry best practices
• Work closely with clinical study teams to ensure/coordinate appropriate documentation of quality event management, including CAPA plans
• Establish key quality metrics and performance indicators to monitor the effectiveness of clinical quality assurance activities
• Analyze data trends, identify areas for improvement, and implement corrective and preventive actions to drive continuous quality improvement

Benefits

• Patient Days
• 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
• 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