GMP Compliance Supplier Auditing role with the Americas Audit Team. A member of the global GMP Compliance and Auditing team this role focuses on suppliers within the Americas Region (North, South and Central America) that provide products, materials, components and services to the Pharmaceutical and Medical Device businesses within AbbVie. Global audits supporting both internal and external supplier teams are possible within the program.

Acting individually or as part of an audit team the successful candidate is responsible for executing on-site and virtual GMP audits of suppliers and third-party manufacturers to assure compliance to applicable global regulations and guidance. The auditor must assess technical and quality systems compliance to applicable regulations, provide clear and factual feedback in the form of a detailed report including observations and assess corrective/preventive actions proposed to remediate observed gaps.

The role requires the successful candidate to be self-managed, proactive, technically capable, and professional while representing the company in an external facing role.

• Bachelor’s Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 4 years) with sufficient exposure to pharmaceutical, medical device, or combination product related industries.
• Total combined experience expected to be at least two years.
  • One year in Quality Assurance with some project management experience in the pharmaceutical, medical device or related industry.
  • One year in compliance auditing is required.
  • Must have a technical background and understand the GMP audit process.
  • Knowledge of global requirements related to Pharmaceutical and Medical Device GMP regulations for quality systems and compliance (FDA, EU, ISO, ICH etc.).
  • Must understand a variety of quality/operational systems that support facility, product design, development, production, distribution, installation, support and service and understand the principles of quality management.
  • The individual must have excellent oral/written communications skills.
  • Personal skills needed include interpersonal skills, tact, open mindedness, maturity, tenacity, self-reliance, organizational/administrative skills and sound judgment. Effective communication skills are essential with an ability to work effectively outside of the company and across functional and technical areas.
• Fluent in English. Including reading, writing and verbal communication.
  • Other languages including Spanish an asset.
  
  

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.