Responsible for managing and implementing quality compliance programs and measures to ensure AbbVie medicines and ingredients are safe, effective, and of appropriate quality. Initiates and leads high impact, global, cross-functional projects as response to complex large scale external compliance standard updates and changes. Benchmarks and participates in industry interest organizations, representing AbbVie’s interests, and influences regulation modification and establishment when possible.
Responsibilities:
•Owns external compliance standard updates, from identification of the change through assessment and implementation for assigned scope
•Manages the assessment and implementation of compliance related changes according to official timelines, acting as the event owner in the corporate Quality Management System
•Actively follows up with Subject Matter Experts (SMEs), such as QA and R&D site contacts, as well as Quality COE leads, to ensure the implementation of changes are completed in a timely manner, including initiating the Document Change Control (DCC) process and updating impacted documents
•Provides interpretation quality compliance standards to functional areas such as Regulatory, QA, R&D, Manufacturing
•Leads the generation of metrics to monitor the performance of compliance
•Leads complex cross-functional initiatives or projects to address or implement compliance
•Proactively represents AbbVie's interests with applicable external industry interest groups and organizations
•Serves as the AbbVie point of contact for external parties related to compliance and communicates to them any comments, questions, or issues from internal SMEs. Leads alignment activities between external and internal stakeholders.
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