Sr. Manager/associate Director, Quality Assurance

About QED Therapeutics & BridgeBio Pharma

• 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.

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

Who You Are

Reporting to the Director, Quality Assurance, the Senior Manager/Associate Director, Quality Assurance will assist in the quality oversight and management of internal and external GXP Quality Systems including, but not limited to: Batch Record Review and Release, Investigations, CAPA, Product Quality Complaints, and external document review and approval. The ideal candidate will have quality assurance experience working in the biotech/pharmaceutical sector.

Responsibilities

• Timely management of batch record review and release to ensure continuous supply for clinical trials
• Management and maintenance of quality systems such as Training, Change Control, Deviations, CAPA, Effectiveness Checks, and Product Quality Complaints
• Experience with analytical instrumentation, methods, validation, and investigations including stability program management
• Ability to effectively multi-task to meet deadlines and commitments
• Assist in inspection readiness activities for GXP activities at QED
• Author and implement QA GXP standard operating procedures (SOPs)
• Develop and deliver training on GXP SOPs and systems
• Assist in the preparation of GXP metric reports for annual review with the Senior Management team
• Other duties as assigned or required including BridgeBio affiliate support

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 7 years of pharmaceutical industry experience in Quality Assurance, as well as experience in small and large molecules in both clinical development and commercial manufacturing
• Thorough knowledge of applicable regulations such as 21CFR Part 11, 210, 211, 312 and 314; ICH Q1–Q10 and E6
• Attention to detail and proper use of tools for information processing and electronic quality management systems
• Ability to effectively multi-task to meet deadlines and commitments

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