Senior Manager, CQA Audit (JAPAC)

📋 Description

• Supports Clinical Quality Audit leadership with the strategic direction of the Clinical Quality
• Assures quality and compliance in a regulated environment including AbbVie policies and procedures
• Advances the AbbVie Quality System through robust collaboration with business partners and other
• Partner with Clinical Quality Assurance and Clinical Development Operations to understand
• Oversee and manage the external suppliers/contractors conducting audits on behalf of AbbVie. This
• Plan and conduct more complex internal audits as well as external routine and for-cause GCP audits

🎯 Requirements

• Bachelor’s degree in science (physical, life, health), a health care profession (e.g., nursing or
• 5-7+ years of experience in the pharmaceutical industry in the fields of clinical development
• Detailed knowledge of quality systems and auditing standards with experience in GCP auditing.
• Extensive knowledge of worldwide clinical regulatory requirements and industry best practices
• Excellent communication skills, including superior negotiation and influencing skills. Acute
• Ability to manage complex issues and distil information. Strong analytical skills and the ability