SVP, Quality Assurance

About BridgeBio

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 20+ 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 aim to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.

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

Who You Are

As the SVP, Quality Assurance, you will play a pivotal role in ensuring the highest standards of quality and compliance across all aspects of pharmaceutical operations for QED and BBGT affiliate companies. You will lead a team of experienced quality assurance professionals and leaders, and collaborate closely with cross-functional teams to maintain and enhance our quality systems. 

Responsibilities

• Overall responsibility for the development and implementation of the vision and strategy, as well as the budget for the quality function
• Manage existing high-performing Quality organization and its capabilities, including providing mentorship and professional development coaching
• Develop and oversee the implementation of comprehensive GXP quality assurance strategies to ensure compliance with regulatory requirements, industry standards, and company policies
• Provide support to the GCP and GMP quality leaders, fostering a culture of excellence, accountability, and continuous improvement
• Establish and manage an internal program for quality and regulatory inspections and audits
• Ensure PAI and BIMO inspection readiness, as well as QA support of post-approval pharmacovigilance systems
• Oversee the design, implementation, and maintenance of robust quality management systems, including document control, deviation management, CAPA (Corrective and Preventive Action), and change control
• Lead regulatory inspections, audits, and quality assessments, ensuring readiness and compliance with FDA, EMA, and other regulatory agencies
• Drive quality risk management initiatives, identifying and mitigating potential risks to product quality, patient safety, and regulatory compliance
• Collaborate with cross-functional teams, including Research & Development (e.g. clinical development, clinical operations), manufacturing, supply chain, and regulatory affairs, to ensure alignment and integration of quality assurance processes throughout the product lifecycle
• Provide strategic guidance and support for product quality issues, deviations, investigations, and recalls, as needed
• Stay abreast of evolving regulations, industry trends, and best practices in quality assurance and proactively implement necessary changes to maintain compliance and drive continuous improvement

Foster a culture of quality and compliance throughout the organization, promoting awareness, training, and engagement at all levels

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 pharmacy, chemistry, biology, or related scientific field; advanced degree (e.g., Master's or PhD) preferred
• Minimum of 15 years of progressive experience in quality assurance roles within the pharmaceutical industry, with at least 5 years in a senior leadership position
• In-depth knowledge of GXP, ICH (International Council for Harmonisation) guidelines, and other relevant regulatory requirements
• Proven track record of successfully leading quality assurance teams and driving continuous improvement initiatives in a pharmaceutical manufacturing environment
• Strong understanding of quality risk management principles
• Excellent leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively across functions and levels of the organization
• Demonstrated experience in leading regulatory inspections (including PAI and BIMO inspections) and interacting with regulatory agencies
• Strategic thinker with the ability to develop and execute comprehensive quality assurance strategies aligned with business objectives
• Detail-oriented, analytical mindset with a commitment to accuracy, integrity, and excellence in all aspects of quality assurance
• Ability to travel regularly

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