VP, Quality

Summary

Join BridgeBio Gene Therapy as their VP, Quality, and lead the quality oversight and management of GXP activities. You will implement and lead continuous improvement initiatives for the quality management system (QMS), ensure continuous clinical and commercial supply of drug product, and manage vendor relationships. The role requires leading pre-approval GXP inspection readiness activities and supporting health authority inspections. You will also oversee internal and external GXP auditing programs, manage investigations, and lead quality for drug product recalls. This is a U.S.-based remote role with quarterly visits to the San Francisco office.

Requirements

• Bachelor's degree in a scientific discipline or biotechnology field
• Minimum of 15 years pharmaceutical industry experience including 10 years in a Quality Assurance management role, as well as experience in small molecules in both clinical development and commercial manufacturing
• Thorough knowledge of applicable regulations such as 21CFR Part 11, 210, and 211; ICH Q1–Q11 and E1-E8

Responsibilities

• Act as GXP Quality head for BBGT and supports other BridgeBio affiliates including business partners as may be required
• Implement and lead continuous improvement initiatives for the quality management system (QMS)
• Ensure continuous clinical and commercial supply of drug product for sponsored clinical trials and approved markets
• Manage the relationships, qualifications, and quality oversight of vendors
• Lead pre-approval GXP inspection readiness activities at BBGT, study sites, CROs, and CMOs
• Support Health Authority and External Inspections as needed
• Oversight of BBGT Internal and External GXP auditing programs
• Provide internal and external change management, investigations, and product quality complaint oversight
• Stability oversight and monitoring for clinical programs
• Quality lead for mock and actual clinical recovery or drug product recall activities
• Identify, design, manage and implement phase-appropriate QA GXP standard operating procedures (SOPs)
• Lead the development and delivery of meaningful GXP metric reports for management reviews with Senior Leadership team
• Day-to-day support, development, and management of direct reports

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
• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities