Director, Clinical 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 Vice President, Clinical Quality Assurance, the Director, Clinical Quality Assurance will define and execute the Clinical Controlled Document Management strategy, and support Clinical functional areas in their management of Clinical Controlled Documents. The Director of Clinical Quality Assurance will be a champion for continuous process improvement.  

The ideal candidate will have experience working in a GCP practice area, preferably in the biotech/pharmaceutical sector. 

Responsibilities

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

• Clinical Controlled Document Management: 
  • Proactively define and drive Clinical Controlled Document management strategy at QED, and partner with other BBIO functions as it relates to ‘centralized’ Clinical Controlled Documents 
  • Develop, review, and revise Clinical Controlled Documents (eg, SOPs, Work Instructions) to ensure alignment with regulatory standards and industry best practices  
  • Manage Clinical Controlled Documents in accordance with format, content and style guidelines, and help ensure accuracy, consistency, and quality 
  • Partner with GMP QA in the management of Quality Assurance Controlled Documents 
  • Act as a single point of contact (SPoC) for clinical functional areas, and collaborate to manage document workflows 
  • Administrate Controlled Document management activities within Veeva including creation, review, approval and archiving processes 
  • Monitor workflow status (including follow up if any delay is noted) to document approval 
  • Foster a culture of continuous improvement and innovation across the organization
• Clinical Project-Specific Training 
  • Design and develop project specific training programs  
  • Administrate training management activities within Veeva, and in partnership with existing Administrators
• Regulatory Authority Inspection Readiness: 
  • Support mock inspections, identify potential compliance gaps, and implement corrective actions, as needed  
• 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

• 2+ years of experience with Veeva administration highly preferred 
• 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 
• A strong team player with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs 
• Ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events  
• Proficient in discerning, high quality verbal and written communication 
• Bachelor's degree in a scientific discipline or equivalent experience  
• Minimum of 6 years of experience in a GCP practice area; Clinical Quality Assurance or similar role preferred 
• Expertise with applicable GCP guidelines  

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