Job Summary
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The Quality Oversight and Compliance Manager will be responsible for driving improvements to existing processes, supporting implementation and monitoring of initiatives related to pan-regulatory information and processes globally through data reporting/metrics analysis.
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About this Role
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This position is an exciting opportunity for a motivated professional to join our team and contribute to the success of our organization.
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Key Responsibilities
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* Identify opportunities for improvement of pan-regulatory data and business processes and procedures.
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* Provide accurate and detailed reports and presentations on the above activities.
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* Identify procedural/compliance gaps associated with in scope processes.
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* Support stakeholders in ensuring inspection readiness.
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* Participate on cross-functional teams to execute quality improvements.
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* Lead investigations and manage CAPA plans.
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Requirements
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* Proven experience in leading investigations and managing CAPA plans.
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* Strong knowledge of the drug development process, Regulatory Affairs, Regulatory Strategy and Submissions Management.
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* Demonstrated ability to adapt core project management skills successfully within a dynamic line environment.
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* Understanding of systems and electronic technologies used to support regulatory and submission process and planning activities.
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* Able to translate data into information to support business decision-making.
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* Experience in managing change in partnership with key stakeholders.
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* Able to lead and operate seamlessly to influence colleagues across the organization.
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* Proven aptitude in project management.
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