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Manager, QA Validation in Los Angeles, CA



$150K - $200K*


Quality Assurance, Technology Management


5 - 7 years

Job Description

The QA Validation Manager will primarily support Computerized System Validation (CSV) activities of in-house and vendor hosted (SaaS) systems, administer IT Change Control process.

Major Duties/Responsibilities

  • Administer IT Change Control and process IT Change Requests (ITCRs) to ensure changes are sufficiently assessed, validated and implemented on-time.
  • Work with IT, Company stakeholders and software vendors to provide SDLC support.
  • Provide QA validation oversight for new standalone and enterprise computerized system implementations, including vendor hosted systems.
  • Author validation lifecycle documentation including VP, URS, FRS, DS, TM, VSR, protocols (e.g. IQ, OQ, PQ), and test scripts (e.g. UAT, Regression Testing) and support execution of validation testing.
  • Ensures compliance with applicable regulations, standards and guidance (US FDA/MHRA/EU/ICH) and Company requirements.
  • System releas
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Valid through: 2020-5-19

About Puma Biotechnology

Puma Biotechnology is a publicly-traded pharmaceutical company (NASDAQGS: PBYI) headquartered in Los Angeles, CA. Puma in-licenses intermediate-stage drug candidates for further development. The company was founded in 2010. The current CEO is Alan Auerbach. Currently Puma licenses three drug candidates from Pfizer: PB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is an irreversible tyrosine kinase inhibitor blocking EGFR, HER1, HER2, and HER4. A new drug application was filed with the FDA for oral neratinib in July 2016. As of December 31, 2015, they had 156 full-time employees.
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* Ladders Estimates