Biometrics Quality & Compliance Lead

Cambridge, MA | Contract

Post Date: 07/19/2018 Job ID: 226865 Industry: Life Sciences

Biometrics Quality and Compliance Lead:

• The Biometrics Quality and Compliance Lead will: Lead Biometrics quality issue investigation (e.g. root cause analysis) & remediation
• Provide support to Biometrics staff with quality activities including CAPAs, process deviations & other compliance related items
• Support for Inspection Readiness and Regulatory Inspections 
• Assess quality risks & assist teams in creation of quality indicators at the study & process level
• Lead end to end Biometrics process compliance quality checks
• Conduct capability assessments of Biometrics vendors including CROs and 3rd Party Vendors
• Other quality departmental support as needed

Required Skills:
• Biometrics staff with quality activities including CAPAs, process deviations  
• Past support for Inspection Readiness and Regulatory Inspections 
• Experience leading end to end Biometrics process compliance quality checks
• Bachelor's Degree in STEM
• 7-10 years relevant work experience in GCP Quality

Desired Skills:
• Masters in STEM
• GCP Audit lead experience
• Biometrics experience is a big plus


 


 

 
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