- Manage deviation investigations, including establishing investigation teams, leading root cause analysis, development of CAPAs, completing product impact assessments and writing compliant documentation of all findings.
- Clear and concise technical writing of complex investigations
- Drive improvements to the investigation process
- Present investigations to regulatory inspectors and internal auditors
- Clearly communicate investigation progress to impacted areas and leadership
- Coordinate and lead cross-functional teams through complex investigations, and complete tasks on-schedule.
- Experience with compliance, problem-solving, root cause analysis, critical thinking, project management, and quality systems.
- Experience leading complex investigations
- Experience participating in and leading cross-functional teams
