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Senior Quality Assurance Manager

2 months ago

San Diego, United States RBW Consulting Full time

We are partnering with a growing biotech in their search for a new (Sr.) Manager, GMP Quality Assurance. Our client is a late-stage, precision oncology biotech focused on developing novel therapeutics for the treatment of cancer.


This position will report to the Head of GMP QA, and be working and closely collaborating with the CMC group and external vendors to ensure compliance, both internally and externally, and working on additional CONTIMP projects with cross-finial leadership to maintain regulatory standards, compliance and Quality throughout the business.


Requirements:

  • Advanced degree preferred
  • Understanding of drug development from early-stage to commercialization and knowledge of FDA and EU cGMP/CGP/GLP regulations and guidance, including ICH documents
  • 5-10+ years of Quality Assurance experience in pharma/biotech in a cGMP pharmaceutical manufacturing environment with early and late-stage products.
  • Needs to have a strong understanding of the external vendor management
  • Plan and execute the daily running of the GMP QA department.
  • Experience developing and implementing quality systems directly related to manufacturing cGMP as well good understanding of GCP and GLP
  • Experience and success in leading a company through cGMP pre-approval and post-approval inspections
  • Prior experience performing at a high level in Regulatory Agency Inspections


The company will offer an excellent compensation package with a strong salary, bonus and stock package, and for the right candidate, a flexible hybrid working arrangement can happen. For more information on this role please forward an up-to-date resume to Alex.bill@RBWconsulting.com