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Our client is seeking a Quality Oversight and Compliance Manager to join a leading pharmaceutical company on a remote basis. You will play a key role in improving regulatory processes and ensuring compliance across global operations.

Key Duties and Responsibilities

• Identify opportunities to improve regulatory data and business processes through metric data analysis in collaboration with Information Management and other stakeholders.
• Provide detailed reports and presentations on activities for senior management, Quality councils, and governance committees, including executive summaries.
• Identify procedural and compliance gaps, establish mitigation plans with process owners, and support inspection readiness and audit preparedness.
• Lead investigations involving process or data deviations, generate metrics, and support Quality Plans and compliance initiatives.

Role Requirements

• Relevant degree in a scientific field such as B.Sc., M.S., or Ph.D.
• Proven experience in regulatory affairs, regulatory strategy, and submissions management.
• Knowledge and practical experience with project management, regulatory systems, and new technology implementation.

Key Words

Quality Oversight / Compliance Manager / Regulatory Affairs / Pharmaceutical / Audit Preparedness / Inspection Readiness / CAPA / Process Improvement / Data Analysis / Project Management / Regulatory Strategy / Quality Manager