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Associate Director, GMP Quality in South San Francisco, CA



$150K - $200K*


Quality Management


11 - 15 years

Job Description

Job Description:

The primary purpose of this position is to provide Quality oversight of drug manufacturing activities at Principia's contract manufacturers. The incumbent will manage and perform the quality role in API, bulk drug product and Investigational Medicinal Product ("IMP") production, including approval of master records, labels, as well as batch disposition. S/he will also assist with implementing and maintaining Principia cGMP quality systems.


  • Drug Manufacturing Quality:
  • Review and approve specifications, master batch records, sampling and testing plans packaging and labeling records, ensuring compliance with study design needs, regulatory requirements and good manufacturing practice ("GMP") regulations.
  • Review of executed batch records and disposition IMP batches, certifying compliance with study, regulatory and GMP requirements.
  • General Quality Activities
  • See More

    Valid through: 2020-4-8

About Principia Biopharma Inc.

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* Ladders Estimates

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