Senior Director, Clinical Quality Assurance - Remote

Overview

The Senior Director, Clinical Quality Assurance at BridgeBio Gene Therapy will oversee quality management and GCP activities, ensuring compliance and excellence in clinical trials.

In Short

• Lead development and maintenance of Clinical Quality Management System.
• Manage inspection readiness and support audits.
• Oversee direct reports and consultants.
• Coordinate quality event management with clinical study teams.
• Provide GCP leadership and expertise.
• Author and maintain QA SOPs.
• Support training oversight.
• Lead process improvement projects.
• Conduct internal and external audits.
• Other duties as assigned.

Requirements

• Expertise in Quality Management System development.
• Strong relationship-building and collaboration skills.
• Negotiation skills and solution-oriented approach.
• Ability to manage multiple projects under time constraints.
• Bachelor's degree in a scientific discipline or equivalent experience.
• 8+ years in GCP or Clinical Quality Assurance.
• Knowledge of GCP guidelines.
• Experience with Veeva platform preferred.

Benefits

• Patient Days to hear from individuals impacted by conditions.
• A culture focused on patient-first values.
• Decentralized model for decision-making.
• Ownership of vision for programs and career path.
• Collaborative, fast-paced, data-driven environment.
• Access to learning and development resources.
• Market-competitive compensation and benefits package.
• Flexible PTO.
• Rapid career advancement opportunities.
• Commitment to Diversity, Equity & Inclusion.