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.