Manager, Global Labeling Operations

• Responsible for implementing and maintaining the effectiveness of the quality system 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.
• Collaborate with key stakeholders to create and execute label change strategy for key label change projects, and labeling changes for early development, submission and production artwork to prioritize deliverables.
• Comply with the labeling change schedule to meet established timelines. Communicate and negotiate exceptions to planned delivery dates.
• Lead role to represent Label Center in early development labeling work including functioning as lead Label Change Coordinator for labeling launch activity.
• Identify continuous improvement ideas to improve right first time and schedule conformance.
• Apply packaging rules and regulations to creation and development of AbbVie’s artwork.
• Evaluate the impact of a label change on associated labels and manufacturing operations.
• Ensure completeness, accuracy, and control of changes in labeling including maintenance of labeling related specifications and documentation associated with these specifications.
• Work closely with Graphics in the creation 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.
• Work closely with Proofreading for the verification of developed label copy against the source documents.

• Bachelor’s Degree in Business / Engineering/Sciences preferred. Equivalent successful industry experience (minimum 4 years) can be considered (see below for guidance).
• Minimum of 4 - 6 years combined experience from totals: Quality/Regulatory– 2 years, Operations – 2 years, Pharmaceutical/Device Regulations – 2 years.
• 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.

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.