Associate Director, Quality Assurance, GMP

BridgeBio Oncology Remote - United States Quality Assurance

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About BridgeBio Oncology Therapeutics

 

Who You Are

Reporting to the Head of Quality Assurance, the Associate Director will assist in the quality oversight and management of GxP activities internally and externally with vendors. The ideal candidate will have extensive quality assurance experience within the biotech/pharmaceutical sector, will be a fast learner and self motivator, have the ability to effectively multi-task to meet short deadlines, possess a high level of attention to detail, and can easily pivot throughout a work day. The ideal candidate should thrive in a busy, fast-paced environment.

Responsibilities

  • Manages the QA oversight of GMP manufacturing vendors, including involvement and review of method validation documentation, stability protocols and reports, GMP drug substance and drug product specifications, GMP drug substance and drug product master and executed batch records, and GMP drug substance and drug product release.
  • Assists in establishing and ongoing management of vendor relationships. 
  • Prepares GxP metric reports and trending for review by management. 
  • Assists in the development and maintenance of GxP SOPs and electronic systems. 
  • Performs other duties as assigned by the Head of Quality Assurance.

Education, Experience & Skills Requirements

  • Bachelor’s degree in a scientific discipline or equivalent experience.
  • Minimum of twelve years industry experience in Quality Assurance, with a minimum of six years within GMP. 
  • Thorough knowledge of applicable regulations.

What We Offer

  • A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak.
  • 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.
  • Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
  • Flexible PTO
  • Rapid career advancement for strong performers
  • Commitment to Diversity, Equity & Inclusion

 

At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
Salary
$180,000$225,000 USD

careers

Associate Director, Quality Assurance, GMP

BridgeBio Oncology Remote - United States Quality Assurance

Apply Now