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AbbVie is seeking a Combination Product Device Quality Manager to ensure the quality of assigned combination products and medical devices. This critical role ensures business objectives are met regarding on-time delivery while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide.
You will be responsible for products including injection devices, infusion pumps, enteral and subcutaneous tubing, and other drug administration system accessories. Products may be produced by AbbVie plants or by third-party manufacturers, in licensing relationships, or co-marketing relationships.
In this position, you will collaborate to develop appropriate regulatory strategies for product brands in concert with Regulatory Affairs. You will ensure delivery of quality elements needed to facilitate on-market support for combination products and medical devices, supporting Global Product Quality Assurance strategy implementation.
You will make key decisions on product quality, compliance, and regulatory conformance issues for medical devices and combination products, ensuring risk-based elevations to AbbVie leadership. This role leads the collection, verification, and improvement of Quality metrics for management review, partnering with senior leadership to develop a clear picture of overall compliance state.