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Senior Analyst, Biometrics Quality & Compliance


Location: Cambridge , Massachusetts
Job Category:

Location: Cambridge, MA
Duration: 12+ Months 

Description:

Job Title: Senior Analyst, Biometrics Quality & Compliance 


Must Haves: 
Experience with regulatory inspections/audits 
Experience with Quality Issue Management (e.g. CAPAs), 
GCP Quality experience, DM, Stats 
Stat Programming experience a plus 

Responsibilities: 
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 (ePRO, MRI, etc) 
Other quality departmental support as needed 

Minimum Education Requirements: Bachelor’s degree required 

Minimum Experience Requirements: 

7-10 years relevant work experience in GCP Quality; Biometrics experience a plus 
• Expertise in global industry regulations and best practices (e.g. Data Integrity, GCP, 21 CFR Part 11) 
• Experience with regulatory inspections 
• Experience with Quality Issue Management (e.g. CAPAs) 
• Deep understanding of drug development and biopharmaceutical industry 
• Strong project management skills; high attention to detail with proven ability to manage multiple, competing priorities & ensure follow through to closure 
• Ability to work effectively across functions and levels; excellent negotiation and problem-solving skills


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