Sr Project Mgr AFP

Location: Thousand Oaks, CA
Date Posted: 08-31-2018
Day to Day Responsibilities:
  • Managing R&D exceptions, which includes providing advice on impact assessment and risk level assessment and leading RCAs as needed
  • Providing oversight of assigned R&D exceptions/ CAPAs and monitoring these to closure
  • Conducting effectiveness reviews and making recommendations on CAPA closure / revisions
  • Representing CAPA status, progress and activities to executive leadership
  • RDCS system entries and updates
  • Verifying objective evidence generation for relevant CAPAs
  • Reviewing exception/CAPA data to identify trends in self-reported exceptions
  • Quality Oversight Activities
  • Contribute expertise to establish and lead R&D processes for exception management
  • Provide quality oversight & leadership for exceptions
  • Manage and monitor input standards for R&D CAPA System (RDCS)
  • Manage exceptions and work with business process owners and project teams to ensure all exceptions are brought to satisfactory conclusion
  • Lead effectiveness reviews of CAPA actions to ensure that solutions have addressed defined root causes
  • Contribute to RDCS evolution strategy
  • Advance risk level assessment and impact methodologies, templates and tools
  • Monitor and evaluate CAPA trends
  • Contribute to inspection readiness efforts
  • Enforce culture of proactive improvement and change
  • Report out to executive leadership on CAPA activities
  • Report out to process owners on process improvement opportunities based on reviews of root causes
Other
  • Represent Quality Oversight on assigned projects / initiatives
  • Maintain contact with professional organizations
  • Keep informed of regulatory requirements related to exception/CAPA management
Summary:
  • Strengthen and advance Amgen’s 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
Other  
  • Represent Quality Oversight on assigned projects / initiatives
  • Maintain contact with professional organizations
  • Keep informed of regulatory requirements related to exception/CAPA management
Basic Qualifications
  • Doctorate degree & 2 years of Compliance or Quality Management experience
  • Master’s degree & 6 years of Compliance or Quality Management experience
  • Bachelor’s degree or & 8 years of Compliance or Quality Management experience
Preferred Qualifications
  • Advanced Degree
  • 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
"This posting is for Contingent Worker, not an FTE"
 
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