Global Labeling Operations Specialist
Vor 4 Tagen
The Global Labeling Operations Specialist role at AbbVie is a dynamic opportunity to lead workflow coordination within artwork production and assume responsibility for key tasks within artwork projects. The position will drive exception management for artwork workflow execution, act as primary contact for stakeholders, and provide support to ensure workflow schedule is maintained.
Key Responsibilities:
- Lead coordination within artwork production in artwork management system to ensure on-time completion
- Complete redlining, tech doc, and disposition tasks in the artwork management system
- Drive exception management for artwork workflow execution and act as primary contact for stakeholders
- Provide support to ensure workflow schedule is maintained
- Complete Change Plan tasks
- Understand performance within their area of responsibility and identify and implement continuous improvement opportunities
- Manage the labeling development and implementation schedule to meet established timelines and negotiate exceptions to planned delivery dates
- Act as owner for specific labeling business processes and assume role of documentation subject matter expert
- Key liaison and subject matter expert for packaging and labeling at AbbVie plants and Third-Party Manufacturers
- Own coordination of regulatory submission required commodity samples
- For US market only; manage drug listing, printed supply notification, and commodity specifications
Qualifications:
- Bachelor's Degree in Business / Engineering/Sciences preferred. Equivalent successful industry experience (minimum 4 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.
- Understands Regulatory, Quality and Supply Chain aspects of labeling and impact of non-compliance.
- Demonstrate ability to work in a highly cross-functional and global environment
- 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.
- Self-motivated and strong focus on details and accuracy
- Strong written and interpersonal communication skills
- High affinity to IT systems
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