Job Summary

A biopharmaceutical company is searching for a person to fill their position for a Remote Quality Event Assessment and Investigation Senior Manager.

Must be able to:

• Be accountable for managing confirmed Significant Quality Event (SQE) cases
• Conduct investigations thoroughly, within required timelines and to compliance requirements
• Lead the SQE team in the development of appropriate Corrective and Preventative Actions

Required Skills:

• PhD/MD and 3 years or equivalent Previous Experience or equivalent education and experience
• 10+ years of pharmaceutical experience
• Experience in data management, operational aspects, GCP Quality, GxP Quality, or regulatory
• Detailed knowledge of clinical trial processes and relationships required
• Knowledge of GCP requirements and applicable SOPs and regulations
• Regulatory inspection experience