Manager, CSV Quality Assurance Job at Meet Life Sciences, Redwood City, CA

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  • Meet Life Sciences
  • Redwood City, CA

Job Description

Manager, CSV IT (Quality Assurance Department)

Hybrid Role - 3x onsite per week in Redwood City, CA

Meet has partnered with an exciting pharmaceutical company that is expanding their CSV QA group! Our client is a commercially successful organization with a robust clinical development pipeline. You'll be joining a well-established QA department to support system implementations and validation efforts.

Key Responsibilities

  • Drive continuous improvement initiatives for the client's Quality Management System (QMS) and support enhancements to validated GxP systems such as Veeva, Argus, SAS and ComplianceWire
  • Collaborate with IT and QA teams to enforce requirements for validated systems
  • Prepare for regulatory inspections and support audits by ensuring validated systems meet compliance requirements
  • Monitor and perform periodic system reviews, identify compliance gaps, and implement corrective actions

Key Qualifications

  • Roughly 8+ years of relevant experience, must have in-house IT QA experience at a pharma/biotech company
  • Thorough understanding of quality systems that support internal GxP activities for pre-clinical, clinical, and commercial products
  • Proficiency in the use of GxP-validated systems such as Veeva (eTMF, Quality, and RIM), SAS, and ComplianceWire

Please reach out to Ryan Moran if you're interested in learning more:

✉: ryan.moran@meetlifesciences.com

Job Tags

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