Associate Director/Director, Quality Assurance

About Eidos Therapeutics & BridgeBio Pharma

Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a clinical-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our product candidate, AG10, is an orally administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.

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, Boston, New York, and Raleigh, 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 eidostx.com/ | https://bridgebio.com

Who You Are:

The Associate Director/Director, Quality Assurance is responsible for executing and managing the GCP Compliance program at Eidos and assigned BridgeBio affiliates. It requires strong judgment skills and business acumen to advise internal and external critical stakeholders on interpretation and compliance with international regulations/guidelines, corporate policies, and standard operating procedures (SOPs).  This individual will be an active participant and critical point of contact in the management of regulatory inspections.

Responsibilities:

• Support the internal and external audit program; manage audit processes/procedures and supervise audit assignments; lead and/or participate in audit activities as needed
• Communicate critical information regarding the significant quality or patient safety risk to Executive Management and key stakeholder
• Partner cross-functionally to support the business with compliance issues/concerns by ensuring appropriate evaluation and mitigation
• Assist the organization with developing and continuously improving processes and systems
• Assist with developing and managing quality documents, including SOPs
• Support the training program, including issuing and tracking training
• Manage and assist with regulatory inspections globally and oversee the development and tracking of regulatory commitments
• Keep abreast of changes in regulations and enforcement actions and make recommendations for changes to policies and practices as needed
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 towards 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 with 12+ years of relevant Quality experience within a biopharmaceutical company or contract research organization; direct industry experience in lieu of education will be considered
• Current knowledge of global GxP regulations 
• Ability to engage in cross-functional interactions with internal and external staff
• Excellent verbal and written communications skills, with a strong customer focus
• Uses broad expertise or unique knowledge and skills to contribute to the development of company objectives and principles and to achieve goals in creative and effective ways
• Develops technical and/or business solutions to complex problems
• Identifies and applies advanced practices, technical principles, theories, and/or concepts and contributes to the development of new regulations and concepts
• Has a comprehensive understanding of current approaches in industry and the ability to incorporate them into Eidos’ programs
• Applies strong analytical and business communication skills

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 – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels seen, valued, and heard

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