AbbVie

Manager Inspection Management (all genders) - (unlimited / fulltime)

Employer
AbbVie
Location
Lake County, Illinois
Posted
May 09, 2022
Ref
2200185
Required Education
Bachelors Degree
Position Type
Full time

Inspection management is responsible for directing, implementing, training and providing consultation for all regulatory inspections worldwide in R&D.  To assure compliance with global regulatory requirements. 

Responsibilities:

  • Manage GxP inspection activities to assure that RD quality system, GCP sponsor activities, manufacturing facilities, testing programs, clinical and pre-clinical study conduct, personnel and records in support of worldwide regulatory filings are able to demonstrate compliance to policies, procedures and applicable government regulations.
  • Influence and train inspection preparation teams comprised of a variety of technical experts.
  • Create and manage fit-for-purpose inspection prep project plans that may include training, practice interviews, mock inspections and associated follow-up for completion of mitigations prior to inspection.
  • Manage responses to health authority findings to ensure the corrective actions are robust, reviewed by appropriate leadership and submitted on time.  This includes tracking all commitments to timely closure in Soltraqs
  • Coordinate GxP pre-approval inspection preparation activities for AbbVie filings/products in support of regulatory filings.
  • Strategize corrective action plans and provide compliance support during implementation to ensure successful inspections.
  • Effectively communicate risks to management, both orally and in writing.