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About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

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

Lake County, Illinois Req ID 2200185 Category Quality Assurance Division AbbVie

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.
Qualifications:

Qualifications:

  • Bachelor’s degree, preferably in physical science (e.g. Chemistry) life science (e.g. microbiology or biology) or pharmacy. 
  • Accreditation by a professional body desirable.  Examples include American Society for Quality (ASQ) Certified Quality Manager (CQM) or Project Management Professional (PMP Certification.
  • Quality Assurance, Quality Control, Regulatory, Manufacturing, Laboratory or Validation background in a regulated industry is preferred. 
  • Working knowledge of product development processes and systems. This could include experience in:  Clinical Operations, Pharmacovigilance, manufacturing/testing of sterile dosage forms, biologics, liquids, solid dosages, active pharmaceutical ingredients or medical devices.
  • Working knowledge of international GXP regulations. 
  • Regulatory inspection experience preferably with direct agency inspector interaction..
  • Strong project management skills are essential including demonstrated ability to lead a team.
  • Excellent oral and written communication skills required with the capability of clearly presenting and justifying quality requirements.
  • Key leadership competencies include cultural awareness, relationship building, ability to influence at all levels of the organization, teamwork building, sound judgment and the ability to make difficult decisions, often at short notice.

 

 

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)
Travel: Yes, 20 % of the Time
Job Type: Experienced
Schedule: Full-time
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