Associate Director, Quality Assurance

Location
Working from home
Posted
Jun 09, 2021
Required Education
Bachelors Degree
Position Type
Full time
QED Therapeutics, a subsidiary of BridgeBio Services, 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 for the treatment of 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 as well as for 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 finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh, with small satellites in other parts of the country. 

To learn more, visit us at  https://www.qedtx.com/ | https://bridgebio.com 

Who You Are:

Reporting to the Director, Quality Assurance, the Associate Director, Quality Assurance will assist in the quality oversight and management of GxP activities internally at QED and externally with QED vendors and service providers including, but not limited to, external document review and approval including batch disposition, Investigations, complaints and change control management. The ideal candidate will have extensive quality assurance experience working in the biotech/pharmaceutical sector. 

Responsibilities:
  • Manages the QA oversight of GMP manufacturing at QED vendors including process development, validation, improvement, batch review, and release
  • Leads the initiation, management, and closure of internal and external GMP Change Controls
  • Assist in the establishment and ongoing management of QED vendor relationships
  • Assist in inspection readiness and hosting activities for GXP activities at QED and QED vendors
  • Author and implement QA GXP standard operating procedures (SOPs)
  • Develop and deliver training on GXP SOPs and systems
  • Prepare GXP metric reports for annual review with the Senior Management team
  • Other duties as assigned or required including BridgeBio affiliate support


Education, Experience & Skills Requirements:
  • Bachelor's degree in a scientific discipline or equivalent experience 
  • Minimum of 10 years pharmaceutical industry experience in Quality Assurance, as well as experience in small 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 enough to learn more about the lives we are looking to impact and a real exchange of ideas as to 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
  • Learning and development training to help employees be the best version of themselves
  • Collaborative business environment
  • Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
  • Excellent benefits package
  • Flexible PTO
  • With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
  • A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
  • Work with the most productive groups of R&D operators in the industry
  • Partnerships with leading institutions
  • A platform for meaningful scientific contributions to shine
  • Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so


We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.