Job Title: Sr. Associate, Biometrics Quality
Location: Cambridge, MA
Duration: 12+ months (possibility of extension)
Roles & Responsibilities:
The Biometrics Quality Team provides leadership and support for the Global Biometrics department, which consists of Data Management, Biostatistics and Statistical Programming.
The Sr. Associate, Biometrics Quality role will be responsible for:
• Conducting reviews to ensure compliance with SOPs and other documents.
• Leading capability assessments of Biometrics vendors including CROs and 3rd Party Vendors (ePRO, MRI, etc).
• Providing support to Biometrics staff with quality activities including CAPAs and process deviations.
• Support for Inspection Readiness and Regulatory Inspections
Required
• 7+ years relevant work experience in Data Management, Biostatistics or Statistical Programming.
• 7+ years relevant work experience in GCP Quality with significant interaction with Data Management, Biostatistics or Statistical Programming.
• Knowledge of GCP and other regulations.
• Experience with Quality Issue Management (e.g. CAPAs) and/or Regulatory Inspections.
• Strong project management skills; high attention to detail with proven ability to manage multiple, competing priorities;
• Ability to work effectively across functions and levels
Please note this is not a GMP Quality role