Associate Director/Director, Clinical Quality Assurance

Title: Associate Director/Director, Clinical Quality Assurance

(Inspection Readiness)

Location: Any Office Location

Type: Full-Time
Workplace: remote

Job Description:

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.

Who You Are

Reporting to the Executive Director, Clinical Quality Assurance, the Associate Director/Director, Clinical Quality Assurance (Inspection Readiness) will lead the process toward defining and executing a fit-for-purpose regulatory authority inspection readiness strategy.

Responsibilities

• Lead the process to define a fit-for-purpose sponsor inspection readiness strategy that aligns with evolving product development and marketing approval pathway
• Advise on site/vendor readiness audit and training process
• Lead routine sponsor cross-functional inspection preparation meetings
• Provide periodic executive summary updates to leadership on the status of inspection readiness, risks, and mitigations
• Track inspection readiness action items, questions and answers, storyboards, and relevant corrective and preventive action (CAPA) plans, etc., through to completion
• Review vendor and investigator site audit reports and any corresponding corrective and preventative actions for adequacy
• Provide inspection readiness-related training as needed
• Author and maintain inspection-related standard operating procedures (SOPs)
• Support the management, maintenance, and evaluation of QED’s Quality Management System and processes for continuous improvement
• Lead process improvement projects as needed
• Provide clinical quality assurance subject matter expertise to the review of clinical trial-related documents
• 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

• Experience with global regulatory authority inspections, including those by US FDA (BIMO), EMA, and other regulatory agencies; inspections of the sponsor, investigator sites, vendors, and/or CROs
• knowledge of ICH/GCP and current regulatory guidelines and intelligence related to regulatory authority inspections
• 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
• Ability to build relationships and work collaboratively with a variety of individuals within the department, company, and external vendors
• Ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
• Strong negotiation skills, flexibility, and ability to provide a solution-based approach to emerging challenges
• Attention to detail and proper use of tools for information processing and electronic quality management systems

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

We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.