Hybrid Associate Director, Clinical Quality Assurance

at BridgeBio

• Job title: Associate Director, Clinical Quality Assurance
• Job type: Full Time
• Experience level: Senior
• Salary: $166,994 - $197,070 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, United States

About the role

• Associate Director providing Clinical Quality Assurance expertise at BridgeBio Pharma. Leading quality management system development and compliance for clinical studies with high expectations for performance.

Responsibilities

• Provide Clinical Quality Assurance (GCP) Subject Matter Expertise (SME) to QED clinical study teams
• Work closely with clinical study teams to ensure/coordinate appropriate documentation of quality event management, including corrective action and preventive action (CAPA) plans
• Support the management, maintenance, and evaluation of QED's Quality Management System and processes for continuous improvement
• Lead small-scale process improvement projects, as needed
• Provide clinical quality assurance SME review of clinical protocols, 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
• Provide support for audits and inspections conducted by external sources (e.g., health authorities) as applicable
• Provide support for quality metrics and performance indicators to monitor the effectiveness of clinical quality assurance activities.
• Other duties as assigned or required

Requirements

• Bachelor's degree in a scientific discipline or equivalent experience
• Minimum of 10 years of experience in a GCP practice area; Clinical Quality Assurance or similar role preferred
• Knowledge of applicable GCP guidelines (e.g., CFRs and ICH)
• Ability to build relationships and work collaboratively with a variety of 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
• Strong negotiation skills, flexibility, and ability to provide a solution-based approach to emerging challenges
• Attention to detail and proper use of tools for information processing and electronic quality management systems

Benefits

• Market leading compensation
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals
• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability
• Subsidized lunch via Forkable on days worked from our office