Manager/Sr. Manager, Quality Assurance Operations

About Eidos Therapeutics & BridgeBio Pharma

Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a commercial 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. Attruby (acoramdis) is an orally administered small molecule designed to stabilize TTR, a 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, 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 eidostx.com/ | https://bridgebio.com

Who You Are

The Manager/Senior Manager, Quality Assurance Operations will be responsible for overseeing the quality aspects of packaging operations conducted at Contract Service Providers (CSPs). This individual will be responsible for leading quality & compliance activities related to routine GMP operations for commercial drug products packaged at CSPs to ensure compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).  

The role requires a deep understanding of commercial packaging operations and regular collaboration with internal stakeholders, external CSPs, and Partners. This position reports to the Associate Director of Quality Operations, Pharmaceutical Packaging. 

Responsibilities

• Perform batch record review and compile batch documentation packages to support disposition activities, including release to market
• Ensure quality oversight of CSPs through remote collaboration/on-site visits, KPI monitoring, and adherence to established quality agreements
• Author and review deviations, change controls, risk assessments, and investigations related to QA operations and systems
• Collaborate in the review of risk assessments and tech transfer/validation/shipping qualification protocols and reports
• Support CMC activities, including reviewing and assisting with regulatory submissions
• Author, review, and update QA Operations SOPs and other quality documents
• Participate in internal and external inspection regulatory inspections and audits
• Identify, assess, and escalate potential quality or compliance issues to management as necessary
• Support and contribute to the Annual Product Quality Review
• Regularly interface with internal and external partners, including CSPs, 3PLs, and other key stakeholders, to align on quality expectations and drive continuous improvement

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 a scientific discipline or equivalent experience
• Minimum of 8+ years of experience in a quality assurance role in the pharmaceutical industry required with at least 5+ years in Quality Operation roles in a current Good Manufacturing Practices (cGMP) environment
• Strong working knowledge of FDA regulations (21CFR, 210/211), ICH guidelines, and global regulations (EU Directives, and ROW) and expertise in the cGMP requirements pertaining to manufacturing and packaging operations (including serialization) in the United States and globally in support of global commercial production activities
• Experience with Veeva platform highly preferred
• Strong communication and collaboration skills with the ability to influence stakeholders in a matrix environment
• Ability to exercise good judgment and make decisions that align with organizational objectives
• Results-driven mindset, taking initiative and ownership of assigned tasks
• Demonstrated flexibility and adaptability in a dynamic, rapidly growing environment
• Commitment to continuous improvement and embracing innovative approaches in daily work
• Up to 15% domestic and international travel required

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