Sr Project Mgr

Thousand Oaks, CA 91320

Posted: 08/31/2018 Employment Type: Contract Industry: Biotech Job Number: 4734

Quality Oversight Senior Manager


Purpose: 
  • Strengthen and advance R&D QMS 
  • Provide expertise to R&D staff on exception Management Processes 
  • Report to executive leadership on progress of Corrective and Preventative Actions (CAPAs) 
  • Lead root cause analyses and create reports of outputs to drive process remediation / improvement efforts 
  • Provide advice for identifying robust corrective and preventive actions and effectiveness checks to improve R&D processes/systems and tools 
  • Identify trends in exception/CAPA data to drive improvement efforts 

 

Basic Qualifications 
  • Doctorate degree & 2 years of Compliance or Quality Management experience 
    OR 
  • Master’ s degree & 6 years of Compliance or Quality Management experience 
    OR 
  • Bachelor’ s degree or & 8 years of Compliance or Quality Management experience 
  • 8+ years in Compliance, Quality or other relevant area of pharmaceutical/ biotech industry 

 

Knowledge 
  • Working knowledge of global regulations impacting R&D activities 
  • Quality Management System oversight & CAPA management 
  • Project Management 
  • Expertise in root cause analysis, impact assessment and risk level assessment 
  • Process management 

 

Location: Onsite/Remote
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