Senior Quality Assurance Specialist

Job Summary

A company is looking for a Senior Quality Assurance Specialist - Computer Systems and Data Integrity.

Key Responsibilities

• Oversee Computer System Validation activities ensuring compliance with regulatory requirements and internal quality standards
• Plan and perform audits of IT vendors, assess compliance gaps, and collaborate on Corrective and Preventive Actions (CAPAs)
• Create and ensure compliance of internal SOPs related to computerized systems and data integrity

Required Qualifications

• Bachelor's degree in information technology or related field
• 6 years of relevant experience, including 4+ years in regulatory settings like FDA 21 CFR 11 or Annex 11
• Experience in clinical trials or the biotech/pharma industry focusing on computerized systems
• Specific QA experience overseeing computerized systems life cycle and data integrity policies
• Familiarity with core IT applications used in regulated environments, such as Veeva and LIMS