Description

Lead quality event investigations and CAPA development within a biopharma environment.

Responsibilities

• Lead and facilitate Quality Event Investigations and subsequent CAPA development with subject matter experts.
• Oversee the standard and timeliness of deviation and CAPA completion.
• Work with business process owners to identify issues and lead improvement initiatives.
• Maintain records of issues, enhancement requests, and support system change implementations within the quality management system.
• Participate in risk assessments and act as a risk facilitator.

Required Skills

• 10+ years of experience in BioPharma.
• 6+ years of experience managing investigations, including deviations and CAPA.
• Proven experience writing investigations.
• Direct experience managing Root Cause Analysis (RCA).
• Knowledge of GxP environments.
• Ability to build and deploy learning tools to support quality event management.
• Experience administering management notifications and escalation processes.

Key Skills

Education

Any Gradute