Senior Investigator, Deviation Management

2 months ago

Holly Springs, United States FUJIFILM Diosynth Biotechnologies Full time

As a Senior Investigator of Deviations Management, you will be responsible for leading and managing complex investigations related to drug substance manufacturing. You will play a critical role in ensuring the quality and compliance of our operations by identifying root causes of deviations, developing and implementing effective corrective and preventive actions (CAPAs), and driving timely closure of investigations.


During project phase:

  • Supports the transfer of the deviation management process from the Denmark site
  • Authors standard operating procedures (SOPs) and work instructions (WIs) to support operational readiness, as needed
  • Performs any “in operations” duties listed below that are required prior to routine operations


During operations phase:

  • Reviews critical, high-risk internal manufacturing investigations
  • Applies systematic methods to conduct investigations.
  • Documents investigation findings and related actions in alignment with Quality Management System requirements
  • Leads junior investigators and coordinates tasks, as needed.
  • Leads the development of complex and potentially, Global CAPAs
  • Collaborates cross-functionally and across sites to maintain alignment on how processes and systems are improved due to investigative findings and/or risk analysis.
  • Coaches and mentors junior staff on investigative techniques and best practices
  • Delivers effective, informative, and engaging presentations regarding metrics, updates, etc. to senior leadership or other stakeholders.


Our ideal candidate will have:

  • Advanced knowledge of systematic cause analysis methods (e.g., Event & Causal Factor charting, Logic Fault Tree or similar techniques)
  • Expert facilitation skills to effectively lead cross functional teams
  • Expert technical writing skills
  • Ability to interpret technical information and documentation from multiple subject matter experts (SME) into a coherent, clear and concise narrative
  • Expertise in performance improvement with a basis in Human and Organizational Performance principles (Fishbone, Taproot or Kepner-Tregoe)
  • Ability to analyze and extrapolate data, and synthesize and determine recommendations, including the analysis of complex problems
  • Team based attitude and ability to work in a global team environment, build relationships, and communicate effectively with others
  • Knowledge of change management, investigations, CAPAs, and Continuous Improvement
  • Trackwise or Veeva experience



Minimum Education and Experience Requirements

  • High School Diploma/GED with 12 years in a GMP environment in Life Sciences industry
  • Willing to travel internationally up to 25% during project phase


Preferred Education and Experience Requirements

  • Associate degree in Life Sciences or Engineering with 10 years of direct experience (e.g., investigations); OR
  • Bachelor’s degree in Life Sciences or Engineering with 8 years of direct experience (e.g., investigations); or equivalent Military experience
  • Prior experience leading complicated manufacturing investigations
  • Prior experience in quality or manufacturing operations

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