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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.

Sr. GCP Compliance Auditor

Primary North Chicago, Illinois Req ID 2211833 Category Quality Assurance Division AbbVie

Primarily responsible for leading and conducting GCP supplier audits in R&D to assess and assure compliance with applicable regulations, guidelines, policies, procedures, and sponsor requirements.

Support GxP supplier audit program.  Support inspections of AbbVie R&D where supplier topics are engaged.

Responsibilities:

  • Interpret, explain, and apply the applicable current regulations, guidelines, policies, and procedures.
  • Plan, organize and lead audits to evaluate supplier R&D facilities, equipment, personnel, methods, practices, computer systems, procedures, records and controls for compliance to protocols, policies, SOPs, and applicable regulations globally.
  • Effectively communicate audit results, both orally and in writing.
  • Review corrective action plans/audit responses for adequacy and approve if adequate.
  • Evaluate the potential risk of compliance deficiencies.
  • Review policies and procedures and suggest improvements.
  • Maintain effective communication of project related information.
  • Provide training and consulting services to the organization to ensure GCP compliance.
  • Escalate potential quality issues to management.
  • Support Supplier Quality throughout the lifecycle of a supplier.
  • Consistently demonstrate AbbVie’s Ways of Working and Leadership Attributes including a collaborative mindset and leadership. Create a learning environment, embrace the ideas of others, and manage innovation to reality.

Qualifications:

  • Bachelor’s degree in a physical science, life science, nursing, pharmacy, or equivalent experience required.
  • 5-7 years of pharmaceutical industry experience in Quality Assurance I Regulatory Affairs.
  • 5-7 years of clinical research and development.
  • Minimum 2 years of QA auditing experience (GCP auditing preferred).
  • Minimum of 7 years total combined experience required (not necessarily the sum of the above).
  • Ability to work independently as well as a team member.
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, 50 % of the Time
Job Type: Experienced
Schedule: Full-time
ABBVIE

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