Manager/Senior Manager, Quality Assurance

Full-TimeQEDAny Office LocationQuality Assurance

Apply Now

About QED Therapeutics & BridgeBio

QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on precision medicine for FGFR-driven cancers and diseases. The company’s first therapy, TRUSELTIQTM (infigratinib), is an orally administered FGFR1-3 tyrosine kinase inhibitor that the US FDA recently approved to treat patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement. We are also evaluating infigratinib for the treatment of other FGFR-driven cancers and the treatment of achondroplasia and other skeletal dysplasias.

QED is derived from the Latin “Quod Erat Demonstrandum” —Thus; It Has Been Proven. Our business is inspired by our values:

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, 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 https://www.qedtx.com/ | https://bridgebio.com

Who You Are:

Reporting to the Associate Director, Quality Assurance, the Manager/Senior Manager, Quality Assurance will assist in the quality oversight and management of GxP activities internally at QED and externally with QED vendors, consultants, and service providers including, but not limited to, quality systems management, external document review, and approval. The ideal candidate will have quality assurance experience working in the biotech/pharmaceutical sector.
Responsibilities:
  • Manages and tracks QED employee and external (consultant and contractor) GxP training records
  • Develop and deliver training on GXP SOPs and quality systems
  • Partner with stakeholders to assess GxP training needs and oversee the generation of training material
  • Assist in the development of GxP training initiatives to enhance the training function, training compliance, and translate strategy to actionable behaviors
  • Ensure compliant documentation of GxP training processes
  • Assist in inspection readiness activities for GXP activities at QED
  • Author and implement QA GXP standard operating procedures (SOPs)
  • Supports the management, maintenance, and evaluation of QED’s Quality Management Systems and processes for optimization and continuous improvement
  • Prepare GXP metric reports as needed in addition to the compilation of the  annual review with the QED Senior Management team
  • Perform internal and external document review and approval
  • Other duties as assigned or required

  • 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 in a scientific discipline or equivalent experience
  • Minimum of 7 years of pharmaceutical industry experience in Quality Assurance or other relevant roles.
  • Knowledge of applicable GXP regulations (e.g., CFRs and ICH)
  • Ability to build relationships and work collaboratively with a variety of individuals within the department, company, and external vendors
  • Ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
  • Strong negotiation skills, flexibility, and ability to provide a solution-based approach to emerging challenges
  • Attention to detail and proper use of tools for information processing and electronic quality management systems
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.
careers

Manager/Senior Manager, Quality Assurance

Full-TimeQEDAny Office LocationQuality Assurance

Apply Now