Senior Manager

Primary Responsibilities
• Lead and facilitate Quality Event Investigations and subsequent CAPA development in accordance with defined timelines and in collaboration with appropriate subject matter experts
• Build, deploy and reinforce learning tools and materials to support quality event management capability development
• Oversee the standard and timeliness of deviation and CAPA completion
• Work with the business process owners to identify issues and improvement requirements and lead those improvement initiatives
• In support of the quality management system module leads maintain records of issues, enhancement requests and support the implementation of system changes
• Administer notification to management and escalation process
• Participate in risk assessments and act as risk facilitator

Candidate Requirements
• GxP experience is preferred
• 10+ years experience in Biopharma experience
• 6+ years managing investigations (deviations, CAPA, etc)
• Experience writing investigations
• Experience managing RCA
• Self motivated