Senior Manager/Associate Director, Quality Operations

Location
Palo Alto, CA, United States
Posted
Aug 19, 2020
Ref
1399001515
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
BridgeBio ultimately exists to help patients. Millions worldwide are afflicted with genetic diseases, but small patient populations and industry reluctance to conduct early-stage development means that for many, treatments have not been forthcoming. We are committed to bridging this gap: between the business case and scientific possibility, between patient and hope.

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

Who You Are

This individual will be responsible for helping develop and execute the Quality strategy for the BridgeBio Gene Therapy portfolio. The incumbent will work closely with other functional area managers and senior management to deliver and maintain cGXP of gene therapy candidates and provide day to day technical leadership and quality oversight for clinical and commercial supply and subsequent trials. This Quality Operations Leader will also interact with the larger BridgeBio portfolio of companies to align on best practices.

Responsibilities
  • Expand and maintain internal and 3rd party facing quality systems that support cGXPs in both US and EU
  • Provide Technical and Quality oversight of day to day cGXP activities in support of the BridgeBio Gene Therapy product portfolio including CMC and Clinical practices
  • Establish best practices for transitions of assays from AD to 3rd party QC operations
  • Lead troubleshooting effort in support of cGXP investigations for OOS or other deviations
  • Lead review of all 3rd party release documentation in support of clinical and commercial supply
  • Ensure all quality systems are developed, implemented and adhered to as required by cGXPs
  • Implement GLP internal testing systems to support regulatory filings
  • Develop an operational plan, budget, resourcing plan for quality organization; work with program management to track program progress and budget
  • Establish robust quality plans to ensure reliable clinical and commercial supply and reduce release delays where possible
  • Lead buildout of quality operations team as needed to support the BridgeBio Gene Therapy portfolio
  • Review of regulatory filings, batch release documents and other materials as required by cGXPs and internally developed quality systems
  • Help establish a quality-focused culture where compliance and patient safety are centric

Education, Experience & Skills Requirements
  • Bachelor's degree in a relevant Scientific or Engineering discipline; an advanced degree is a plus
  • Minimum of 8 years of experience in cGXP manufacturing of recombinant viral gene therapy vectors, vaccines or complex biologics
  • Experience with both clinical and commercial manufacturing is required
  • Previous supervisory experience is highly preferred

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