Senior 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 Sr. Director, Clinical Quality Assurance will define and support the quality oversight and management of GCP activities internally at QED and externally with service providers. Further, the Sr. Director, Clinical Quality Assurance will identify and coordinate quality projects leading to process improvement and hence an enhanced status of inspection readiness.

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:

• Process Improvement
• Identify opportunities for process improvement and lead initiatives to enhance efficiency, effectiveness, and compliance
• Implement best practices and standardized processes to optimize quality assurance activities
• Foster a culture of continuous improvement and innovation across the organization
• Regulatory Authority Inspection Readiness
• Lead (or support) mock inspections, identify potential compliance gaps, and implement corrective actions as needed
• Vendor, Site and Internal Audits
• Lead internal audits
• Lead or support external audits, as deemed necessary
• Review vendor, site and internal audit responses for adequacy and identify and propose relevant sponsor process improvement tasks/initiatives
• Standard Operating Procedures (SOPs)
• Develop, review, and revise to ensure alignment with regulatory standards and industry best practices
• Ensure SOPs are clear, comprehensive, and accessible to relevant stakeholders
• Corrective and Preventive Action
• Work closely with clinical study teams to ensure/coordinate appropriate documentation of quality event management, including corrective action and preventive action (CAPA) plans
• Quality Metrics and Reporting
• Establish key quality metrics and performance indicators to monitor the effectiveness of clinical quality assurance activities
• Analyze data trends, identify areas for improvement, and implement corrective and preventive actions to drive continuous quality improvement
• Prepare comprehensive reports and presentations on quality assurance metrics and initiatives for senior management
• 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

• 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
• 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

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
  
  

At BridgeBio, 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. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.

Salary

$220,000—$265,000 USD