Sr/ Director, Quality Assurance

COMPANY BACKGROUND

GondolaBio is a collection of biopharmaceutical companies focused on developing next-generation therapeutics for genetic diseases. Originally carved out of BridgeBio, GondolaBio secured $300M in private financing from external investors in 2024 and became an independent company within the BridgeBio ecosystem. GondolaBio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases.

To learn more, visit us at gondolabio.com

Who You Are

Sr/Director of Quality Assurance is responsible for the development, maintenance, and oversight of Good Clinical Practice (GCP) activities related to clinical trials. The primary responsibilities will be to ensure that both quality and compliance of clinical trials with respect to company policies and procedures, applicable regulatory requirements (US FDA, ICH, and country specific), along with current industry standards and practices. The position will work closely with clinical study teams to manage and support a culture of quality, regulatory compliance, and continuous GCP inspection readiness.

Responsibilities

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

• Lead the development, management and maintenance of Clinical aspects of GBIO’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/contractors, 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
• ·n 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 (Vendor Audits). Review audit reports, and any corresponding corrective and preventative actions for adequacy
• Work with GMP QA Team and CMC to address enterprise wide QMS topics
• Other duties as assigned or required

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
• Thorough knowledge of applicable regulations such as 21CFR Part 11, 210, 211, 312 and 314; ICH Q1–Q10 and E6
• Minimum of a Bachelor's degree in a scientific discipline or equivalent experience, Master’s Degree in scientific discipline preferred.
• 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

• 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

At GondolaBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. GondolaBio is a multi-state employer, and this salary range may not reflect positions based in other states.

Compensation : $223,000 to $280,000