Hybrid Manager, Quality Assurance, Product Complaint en Bridgebio

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 Quality Assurance Manager, Product Complaint, will report to the Sr. Manager, QA, Product Complaints. This position will manage product quality complaints for commercial marketed products and clinical trial materials. The position will ensure compliance with the current regulated standards and internal procedures. This position will require strong cross-functional collaboration with internal stakeholders and external parties.  

Responsibilities

• Maintain and continuously improve global processes related to complaint handling, mock recalls, recalls, and notifications 
• Ensures timely complaint initiation, investigation/analysis, reportability assessments, and reporting to appropriate domestic and international governments as required, and complaint closures 
• Perform monthly reconciliation, trend reports and metrics for Complaints to identify potential quality issues 
• Coordinate with SMEs to ensure all product complaint investigations are completed with minimal guidance and ensure investigation action plans and final investigation summaries are accurate, including appropriate corrective actions, and follow the company’s standards 
• Collaborate with departments (e.g. Affiliates, Manufacturing /Packaging sites, Vendors) to establish appropriate, efficient, and timely investigation strategies 
• Collaborate with key stakeholders to foster effective interdepartmental and cross-functional partnership 
• Escalate to management of potential quality or regulatory issues that may affect product quality or regulatory compliance 
• Participate in audits and regulatory inspections 
• Establish work priorities to meet targets and timelines and effectively manage competing priorities with minimal escalations 
• Serve as the Quality representative in cross-functional and multi-site teams 
• Other duties as assigned  

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 or equivalent in operations, science, mathematics, or engineering required 
• A minimum of 5+ years of experience working in a Biotech or Pharmaceutical FDA regulated industry in QA or a related field or an equivalent combination of education, training, and/or experience from which comparable knowledge, skills, and abilities have been attained 
• Extensive knowledge of US, European and Global product quality complaint handling requirements, and associated guidelines 
• Experience with implementing and maintaining pharmaceutical quality management systems 
• Excellent analytical and critical thinking skills, with keen attention to detail 
• Proficiency in eQMS, Microsoft Office, Google Docs, etc. 
• Experience with commercial marketed products 
• Ready to embrace companies core values and diverse corporate culture 

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