Sr. Director, Clinical Quality Assurance

About BridgeBio Gene Therapy & BridgeBio Pharma

BridgeBio Gene Therapy, a subsidiary of BridgeBio Pharma, is focused on discovering and developing drugs for patients with grievous genetic diseases. We do this by:

Finding the right starting points to target diseases at their source.

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.

Building products with world-class R&D personnel.

We employ industry-leading scientists that work closely with leading academics to prosecute a wide variety of drug programs at the highest level of scientific rigor. Our team combines biopharmaceutical veterans with up-and-coming leaders to drive entrepreneurial thinking grounded by experience.

BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.

Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.

To learn more about our story and company culture, visit us at https://bridgebio.com

Who You Are

Reporting to the Vice President, Clinical Quality Assurance, the Sr. Director, Clinical Quality Assurance, will define and support the quality oversight and management of GCP activities internally at BBGT (and other affiliates as directed) and externally with BBGT vendors, consultants, and service providers, including, but not limited to, quality systems management, document review, and approval.

Responsibilities

In partnership with Clinical QA management, drive strategy and execution of the following:

• Lead the development, management and maintenance of Clinical aspects of BBGT’s Quality Management System procedures and related processes for continuous improvement
• Lead inspection readiness activities and provide support for audits and inspections conducted by external sources (e.g., health authorities) as applicable
• Manage direct reports and consultants, as needed, in the pursuit of Clinical Quality Assurance objectives
• Partner with clinical study teams to coordinate appropriate and timely documentation of quality event management, including corrective action and preventive action (CAPA) plans, as necessary
• Provide Clinical Quality Assurance (GCP) leadership and Subject Matter Expertise (SME) to clinical study teams
• Author and maintain QA Standard Operating Procedures (SOPs). Support management of other functional area SOPs
• In collaboration with functional area leads, support training oversight
• Lead process improvement projects as needed
• Provide Clinical Quality Assurance SME to reviews of clinical protocols, amendments, Clinical Study Reports, 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
• Other duties as assigned or required

No matter your role at BridgeBio, successful team members are:

• Patient Champions, who put patients first and uphold strict ethical standards
• Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
• Truth Seekers, who are detailed, rational, and humble problem solvers
• Individuals Who Inspire Excellence in themselves and those around them
• High-quality executors, who execute against goals and milestones with quality, precision, and speed

Education, Experience & Skills Requirements

• Demonstrated expertise in guiding development of the Quality Management System
• 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
• 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
• Expertise with applicable GCP guidelines
• Experience with Veeva platform highly preferred

What We Offer

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
• 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. Learn more about how we do this here
• A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
• 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