Sr. Project Manager – Biotech/Pharma Quality/Compliance Oversight (JP4675)

Location: Thousand Oaks, CA
Date Posted: 09-02-2018
Job Title: Sr. Project Manager – Biotech/Pharma Quality/Compliance Oversight (JP4675)
Location: Remote or Thousand Oaks, Ca
Employment Type:  Contract
Duration: Initial 6 months with likely extension
Business Unit:  GLP Compliance Strategy
 
3Key Consulting Inc. is looking for a Quality Oversight Senior Manager GCF 6 for a global bio-pharmaceutical company.
 
Purpose:
• 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
 
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


Top Must-Have Skill Sets:
• 8+ years in Compliance, Quality or other relevant area of pharmaceutical/ biotech industry
• Working knowledge of global regulations impacting R&D activities
• Quality Management System oversight & CAPA management
 
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
 
Basic Qualifications:
Doctorate degree and 2 years of industrial design/planning experience OR
Master’s degree and 4 years of industrial design/planning experience OR
Bachelor’s degree and 6 years of industrial design/planning experience OR


Employee Value Proposition:
Contribution to advancing the quality management system.
 
Red Flags: Not enough experience in required field.
 
Interview process:  Phone screen followed by in-person interview.
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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