IT Quality Specialist

Do you have experience validating data in an environment that included cell delivery or immune protection?

SQA has a project that is focused on the validation and compliance of a drug delivery device.  The therapies are gene and cell based.  We are looking for a Senior Quality and Compliance specialist to help govern the research and development phases of this device, from a QMS, GxP and compliance perspective.   You will be part of a centralized IT Quality and Compliance team.
Critical Success Factors:
  • Performing Quality Assurance function related to Computerized Systems / Infrastructure
  • Proficiency with regulations related to FDA / MHRA regulations
  • Use of computerized quality management systems
  • Experience with validation of Enterprise / Lab Computerized Systems.
  • Quality metrics, dashboards, analysis and improvement programs
  • Knowledge of GAMP and Agile validation lifecycle and methodologies

Job ID: 2001-5840
SQA is an equal opportunity employer and supports workforce diversity.