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Manager/Sr. Manager, Quality Assurance

Remote - United States

About QED Therapeutics & BridgeBio Pharma

QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. Achondroplasia is the most common form of genetically-driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we seek to provide an option to children living with Achondroplasia and their families.
 
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, 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 Associate Director, Quality Assurance, the Senior Manager, Quality Assurance will assist in the quality oversight and management of internal and external GxP Quality Systems and processes including, but not limited to: Document Control, Training, and Quality Metrics. The ideal candidate will have quality assurance experience working in the biotech/pharmaceutical sector. 

Responsibilities

  • Management of QED Training, including onboarding, curricula, learner roles, training matrices, and annual GxP training
  • Develop and deliver training on GXP SOPs and systems
  • Support management and maintenance of quality systems such as Document Control, Change Control, Deviations, CAPA, and Effectiveness Checks
  • Author and implement QA GXP standard operating procedures (SOPs)
  • Assists in the management, maintenance, and evaluation of QED’s Quality Management Systems and processes for optimization and continuous improvement
  • Assist in the development and preparation of GxP metric reports and …
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