Clinical Operations

• Support assigned countries and region through implementation and execution of proactive quality management activities
• Maintain collaborative relationships with RDQA functions supporting clinical research in designated Affiliates
• Establish relationships with clinical development leaders and staff to advance the AbbVie Quality System and achieve first-pass health-authority approval
• Oversee quality and compliance in a regulated environment under AbbVie policies, procedures, and country/regional standards
• Lead or collaborate on risk identification and mitigation/control strategies for clinical research and clinical trials
• Review quality and compliance data to support continuous improvement and establish quality measures
• Drive quality strategy across designated countries and region with RDQA AREA personnel
• Manage fit-for-purpose governance and oversight aligned with the One AbbVie Quality System
• Identify trends, root causes, and risks affecting clinical research
• Maintain regulatory preparedness and support Affiliates R&D Management on Quality System health
• Maintain awareness of applicable regulations and develop quality standards for assigned countries and region
• Support supplier visits, audits, and vendor qualifications
• Develop inspection strategy and provide inspection-readiness support for local and regional Health Authority inspections
• Provide oversight, support, and follow-up for inspection reports and participate in inspections as needed
• Determine need for country/process assessments and audits; conduct audits as required
• Communicate audit results orally and in writing
• Review and approve corrective action plans and audit responses
• Support robust audit and inspection responses through coaching and education
• Mentor AREA Managers, AREA Associates, or line management as an additional lead responsibility

Explore Senior Manager, Clinical Quality Assurance at AbbVie. Review requirements and application details.

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