We are seeking a skilled professional to fill an exciting opportunity as an Investigations Lead with a leading multinational organization. This role offers an excellent chance for individuals looking to join a reputable company and contribute their expertise in a dynamic environment.
As an Investigations Lead, you will be responsible for managing investigations related to fill/finish/inspection and packaging deviations. You will work closely with cross-functional teams to apply process, quality, compliance, and analytical knowledge. Your technical writing skills will be essential in documenting all deviation incidents, and your project management skills will enable you to drive improvements to the investigation process.
* Manage deviation investigations, including establishing investigation teams, leading root cause analysis, development of CAPAs, completing product impact assessments, and writing comprehensive 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
* Project management of the investigations end-to-end
* Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues
* Build effective relationships across functions
* Navigate through ambiguity and provide a structured problem-solving approach
* Able to apply inductive and deductive reasoning in the investigation process
Requirements:
Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (i.e. process development, engineering, quality) OR Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (i.e. process development, engineering, quality) OR 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment.
Detailed technical understanding of fill/finish operations.
Experience with compliance, problem-solving, root cause analysis, critical thinking, project management, and quality systems.
Experience leading complex investigations and technical writing.
Experience presenting to inspectors during regulatory inspections and internal audits.