• Manage milestones, timelines and deliverables for audits/inspections and Quality System initiatives
• Proactively leads/supports initiatives to improve quality systems in the organization
• Support audit/inspection activities (e.g. preparation, logistics, audit close out)
• Participate in audits/inspections
• Create audit/inspection training material, reference cards and slide decks
• Compile metrics, create slide deck and update performance boards
• May cross-train in other disciplines within Quality Systems
• Minimum 4 years of in Pharmaceutical or Biotech industry
• Good knowledge of GMP regulations, Quality compliance and audit/regulatory inspections
• Organized, and capable of managing tasks on multiple, concurrent projects.
• Ability to work effectively and to respond quickly in a fast paced environment.
• Independent decision making capability and ability to think conceptually and understand impact of decisions on overall compliance and the business
• Team player with the ability to work cross functionally and across all levels within the organization.
• Must possess excellent verbal and written communication skills; good interpersonal skills.
• Strong background of MS Office Tools (Access, Excel, OneNote, PowerPoint, SharePoint, Visio, and Word) - Emphasis on Access, Excel and SharePoint
• Bachelors degree in Life Sciences