Quality Assurance Manager

2 days ago


Limerick, Limerick, Ireland Regeneron Ireland DAC Full time

Required Skills and Qualifications:

  • Knowledge of applicable federal, state, and local regulations (e.g., GDPR), rules, policies, and procedures such as FDA Guidance on Data Integrity, EMA Data Integrity Guide, and WHO Guide to Data Integrity.
  • Demonstrated success in implementing and managing policies and standards within a regulated environment.
  • Excellent communication and collaboration skills.
  • Strong stakeholder management and influencing skills.
  • Experience in use of quality systems and/or change management.

Benefits:

  • Bachelor's degree or equivalent combination of education and experience in pharmaceutical/FDA regulated work areas such as: data management & operations, quality assurance, compliance, manufacturing operations, quality control, or IT.
  • 7+ years of professional experience.


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