VP, Quality BridgeBio Gene Therapy

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
 
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. 
 
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.

Affiliate Overview

BridgeBio Gene Therapy, an affiliate within of BridgeBio Pharma, is focused on discovering and developing drugs for patients with grievous rare genetic diseases by finding the right starting points to target diseases at their source and by building products with a world-class R&D personnel team. Using a combination of a systematic assessment of the genetic disease landscape and informed diligence on the latest research, we find indications with clear mechanisms of pathogenesis that are ripe for translation into disease-modifying drugs.

What You'll Do

Reporting to the Senior Vice President of Quality Assurance, the VP, Quality BridgeBio Gene Therapy leads the quality oversight and management of GXP activities internally and externally with BBGT vendors, service providers and business partners including, but not limited to, clinical study oversight, drug safety support, external document review and approval, batch disposition, validation activities, production, and commercial launch. The ideal candidate will have extensive GMP and GCP quality assurance experience working in the biotech/pharmaceutical sector. 

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

Where You'll Work

This is a U.S.-based remote role that will require quarterly, or as needed, visits to our San Francisco Office. 

Who You Are

• 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 clinic