Senior Manager, Clinical Quality Assurance
AbbVie
AbbVie seeks a Senior Manager of Clinical Quality Assurance to lead proactive quality management and regulatory compliance across R&D and clinical research activities in designated countries. The role focuses on driving quality excellence, ensuring data integrity, and supporting first-pass regulatory approvals within a global affiliate network.
Responsibilities
- Maintain collaborative relationships with RDQA functions and clinical development leaders across assigned affiliates
- Oversee quality and compliance in regulated environment, implementing AbbVie policies and regional standards
- Lead risk identification and mitigation strategies for clinical research activities with continuous improvement reviews
- Conduct audits to assess regulatory compliance and approve corrective action plans
- Support health authority inspections, develop inspection strategy, and provide inspection-readiness support
Requirements
- Bachelor's degree in biology, nursing, pharmacy, or medical science
- 8+ years biopharmaceutical or medical device quality assurance, compliance, or clinical research experience
- 3+ years in leadership roles managing people and/or initiatives
- Strong knowledge of quality systems, auditing standards, and quality management
- Understanding of local and global regulatory requirements and health authority perspectives
- Analytical skills with ability to organize work logically and communicate findings clearly
- Ability to influence stakeholders without direct authority and negotiate effectively
Vacancy posted 8 days ago
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