Director, Quality Assurance

About QED Therapeutics & BridgeBio Pharma

QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. Achondroplasia is the most common form of genetically-driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we seek to provide an option to children living with Achondroplasia and their families.
 
Our business is inspired by our values:

• PUT PATIENTS FIRST
• LET SCIENCE SPEAK
• EVERY MINUTE COUNTS
• THINK INDEPENDENTLY
• BE RADICALLY TRANSPARENT

FGFR=fibroblast growth factor receptor.

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, Raleigh, and with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, Switzerland, and are expanding across Europe.

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

Who You Are

Reporting to the Executive Director, Quality Assurance, the Director, Quality Assurance will assist in the quality oversight and management of GxP activities internally at QED and externally with QED vendors and service providers, including, but not limited to, inspection readiness and management, quality systems management, external document review and approval including batch disposition. The ideal candidate will have extensive quality assurance experience working in the biotech/pharmaceutical sector.

Responsibilities

• Assists in the design, preparation, and execution of inspection readiness activities, including active inspection support
• Participate in the coordination and execution of the internal audit program
• Track and Prepare GXP internal and external metric reports periodically, including annual review with the Leadership team
• Manage mock and live clinical recovery or drug product recall efforts
• Support the planning, design, and implementation of commercial readiness initiatives
• Contribute to the management, maintenance, and evaluation of QED’s Quality Management Systems and processes for optimization and continuous improvement
• Ensures GXP compliance with regulatory requirements and internal procedures
• Aid in the continuous supply of drug products for sponsored clinical trials and business partners
• Author and implement QA GXP standard operating procedures (SOPs)
• 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

• Bachelor's degree in a scientific discipline or equivalent experience
• Minimum of 10 years pharmaceutical industry experience in Quality Assurance, as well as experience in both clinical development and commercial manufacturing
• Thorough knowledge of applicable GXP regulations (e.g., CFRs and ICH)
• Ability to build relationships and work collaboratively with a variety of individuals within the department, company, and external vendors
• A strong team player with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs
• Travel – varies at 10-25% based on needs

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