AbbVie

Senior GCP Compliance Auditor

Employer
AbbVie
Location
Lake County, Illinois
Posted
Jun 03, 2021
Ref
2101391
Required Education
Bachelors Degree
Position Type
Full time
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.

*This is a US remote opportunity

GCP QA operations is responsible for ensuring high quality clinical trials are performed in compliance with worldwide regulatory expectations. The ultimate products are regulatory submissions which demonstrate good scientific rationale and interpretation plus inscrutable data integrity. The goal of the department is appropriate protection of all human subjects participating in AbbVie Clinical Trials. Responsibilities also include: Management of all quality-related activities to deliver consistent, high quality documents and clinical program activities for R&D. Ensure that R&D remains in compliance with worldwide regulatory expectations and requirements. Lead and develop strategy for global Quality Assurance in alignment with R&D strategies.

  • Assure that R&D remains in compliance with Corporate and Divisional policies and procedures and all applicable worldwide regulations
  • Interpret, explain and apply the applicable current regulations, guidelines, policies and procedures
  • Plan, organize and lead multiple GCP Investigator Site Audits, system/process audits and vendor audits
  • Effectively communicate audit results, both orally and in writing. Review corrective action plans/audit responses for adequacy and approval if adequate
  • Evaluate the potential risk of compliance deficiencies
  • Review policies and procedures and suggest improvements
  • Initiate, manage, and/or participate in quality improvement projects
  • Work independently as well as a team member
  • Mentor, coach and train QA auditing staff
  • Prepare and present project progress reports to update management and keep the team(s) informed

Qualifications
  • Bachelor’s degree in a physical science, life science, pharmacy, engineering or equivalent experience required
  • At least 2 years’ experience in pharmaceutical industry (Quality Assurance, Project Management or equivalent area)
  • Knowledge of quality management systems, Good Clinical Practice and related regulatory requirements
  • Good English skills
  • Thorough, documented understanding/knowledge of international GCP regulations. Knowledge of the development of pharmaceuticals
  • Prior to assignment as a (Lead) GCP-Auditor the employee is required to participate in at least one external auditor training, as well as, at least two attendances at audits as Co-Auditor. These requirements can be fulfilled during an “on the job training”

#LI-remote


Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 50 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.