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Senior Label Change Coordinator

Company: AbbVie
Location: Crystal Lake
Posted on: October 13, 2019

Job Description:

Global Label Management (GLM) in Operations Quality is responsible to deliver the Perfect Label; assuring timely implementation and accurate content. GLM operates as a global integrated organization and facilitates the end-to-end labeling implementation process. Making the perfect label possible every time. The Senior Label Change Coordinator (SLCC) in GLM's Label Centers is responsible for the execution of label changes for the AbbVie products assigned to his or her team. Operating in a global and cross-functional environment, the LCC ensures that quality of the labeling meets the highest AbbVie and industry standards. Senior LCC holds a significant role for process ownership. Key Responsibilities: Responsible for implementing and maintaining the effectiveness of the quality process by delivering the "perfect label" to our customers through an effective and efficient label change management process. The Perfect Label is defined as compliant with content requirements and timely implementation, both internal and external to AbbVie. Complete work according to established priorities, policies, practices and procedures to assure deliverables meet requirements. Collaborate and communicate with internal and external key stakeholders to prioritize deliverables to successfully execute change requests. Facilitates meetings with stakeholders as required. Comply with the labeling change schedule to meet established timelines. Communicate and negotiate exceptions to planned delivery dates. Ensure adherence to right first-time principles from start of change to final artwork. US Market Only: Evaluate the impact of a label change on associated labels and manufacturing operations. Ensure completeness and accuracy for labeling changes. Creation of labeling specifications and associated documentation if applicable. Work closely with Label Center functions in the creation and verification of label artwork, mock ups utilized for regulatory submissions, and assist commercial, as required, in the development of label designs for packaging and labeling commodities. Pull and evaluate GLM performance metrics and present to team lead. Initiate root cause analysis and action plans, if necessary, for business need Identifies continuous improvement opportunities. Responsible for implementing Change Plan tasks. Participate in local and global end to end labeling improvement projects. Identify and elevate inconsistencies of established practices versus procedures or gaps in procedures to team lead. Implement corrective and preventive actions. Act as primary liaison for affiliates, manufacturing plants, TPMs and brand teams. Foster the overall relationship; participate in Business Review Meetings as needed. Champion new product launches from an LCC perspective in alignment with the overall launch strategy. Business process owner (BPO) for relevant aspects of the label change process, acting as SME for process, training and documentation changes. As BPO play a significant role in internal and external projects related to the end to end labeling process. Bachelor's Degree in Business / Engineering/Sciences preferred. Equivalent successful industry experience (minimum 6 years) can be considered. Preferred: Labeling experience in Pharmaceutical or Biotech industry. Minimum of 4 - 6 years combined experience from the following areas: Quality/Regulatory, Operations, Pharmaceutical/Device Regulations. Fluency in English. Individual must have a breadth of experience to establish and maintain credibility across functions, with stakeholders and with senior management. Ability to motivate and influence others over whom they have no direct authority. Knowledge of applicable regulations and standards affecting Pharmaceutical, Device, Device/Combo Products, specifically regulations and standards affecting the Packaging and Labeling Quality System. Ability to logically reason, solve problems, and make decisions on key issues independently. Self-motivated and strong focus on details and accuracy. Strong written and interpersonal communication skills. High affinity to IT systems. Successful demonstration of project management skills.

Keywords: AbbVie, Crystal Lake , Senior Label Change Coordinator, Other , Crystal Lake, Illinois

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