We are recruiting for a senior role in the life science industry. This is an excellent opportunity to join a company that excels in its field.
Job Role
As an Investigations Lead, you will be responsible for leading investigations into fill/finish/inspection and packaging deviations. You will apply your knowledge of process, quality, compliance, and analytical skills to drive improvements to the investigation process.
Responsibilities:
* Manage deviation investigations, including establishing investigation teams, leading root cause analysis, developing corrective actions, conducting 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.
* Presentation of investigations to regulatory inspectors and internal auditors.
* Clear communication of investigation progress to impacted areas and leadership.
* Coordination and leadership of cross-functional teams through complex investigations and completion of tasks on-schedule.
* Project management of the investigations end-to-end.
* Presentation of complex topics to large and small groups at various levels and clear communication of complex issues.
* Building effective relationships across functions.
* Navigating ambiguity and providing a structured problem-solving approach.
* Application of inductive and deductive reasoning in the investigation process.
Qualifications and Experience:
* 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.