Manager Global Labeling Operations

Manager Global Labeling Operations

Baxter International

San Gwann, Malta

The Labeling Manager leads a team of Project Leaders to support the product labeling development or modification and implementation for the Nutrition business, ensuring that labeling is completed within timelines committed. The Manager also has the accountability of communicating regularly with regional based labeling stakeholders and the artwork design team to ensure labeling production timelines are maintained. This role will also ensure the compliance to labeling format and content standards specialized drawings, and general specifications related to labeling requirements. The Manager will handle a variety of complex issues associated with development of labeling for new platforms and partner with stakeholders at the plants to drive for any resolution around issues with label printing technology at manufacturing plants. This person will also continue to drive initiatives that aim to improve Baxter labeling, including investigating and developing solutions to problems that hinder the labeling process effectiveness and efficiency, and that contribute to continuous improvement.

Essential Duties and Responsibilities:

• Responsible for managing multiple labeling projects, including planning, organizing, execution, tracking, and driving labeling development projects and/or labeling changes to ensure projects are consistently completed and implemented per project schedules and change control plan(s). Proactively identify and resolve issues that may impact project deliverables.
• Responsible for serving as direct supervisor for Project Leaders. Manages overall coaching, training, development for direct reports. Reviews project coordinator work and deals with more complex issues as they arise.
• Collaborates with multi-functional Subject Matter Experts (SMEs) to ensure all required inputs are identified and compiled for labeling changes. Ensuring driving for resolution but relying on SMEs for decision.
• Drives labeling projects (new and lifecycle management) through both the labeling and change control processes, and oversee change control activities related to label changes, from initiation through implementation, to ensure that change controls respect project deliverables and target dates, and are in compliance with the applicable standards and procedures.
• Manages language translations relations with translations service companies and manage translations activities; facilitate the review and approval of translations
• KPI and metrics: ensures processes and tools are leveraged and accurately utilized to capture data and measure efficiency and effectiveness of the labeling process. Collects and reports data for KPI and metrics measurements.
• Ensures that processes and procedures related to labeling activities and the output of the organization are compliant to applicable requirements and to the Corporate Quality Management System, and fulfills business requirements.
• Interacts with and partners with internal and external stakeholders, and be responsible for communication and facilitation of meetings with labeling SMEs, such as Product Design Owner (PDO), Regulatory Affairs, Supply Chain, Manufacturing, Quality, Packaging, Material Suppliers, and Third-Party/CMO companies.
• Will perform other duties as assigned.

Qualifications for this role:

• Must have thorough knowledge of the labeling printing processes at suppliers and in the manufacturing process.
• Is organized, has analytical mind and comfortable with data analysis and numbers and LEAN and EMS principles.
• Strong Leadership with excellent teamwork and collaboration skills along with excellent people management skills as well as experience working in matrix environment.
• Quality System processes knowledge and experience (e.g., change control, and nonconformance/CAPA specific knowledge).
• Ability to support and drive business targets associated with the Global Labeling team (e.g., prioritization, cycle time, accuracy, compliance).
• Strong leadership skills and demonstrated success in managing a small team.
• Strong communication skills: interact efficiently with all levels of local and international organization. Ability to cascade information both ways and ensure consistent, concise, clear messages to all, ability to influence others skills.
• Stress resistant; ability to deal with ambiguity and make timely decisions.
• Self-driven and motivated with the ability to work independently as needed; Customer focused.
• Ability to work in an international and matrix environment.
• Critical thinking and the ability to challenge the status quo; good problem solving skills.
• Results oriented with a process and quality driven approach.

Education and experience:

• Bachelor level degree or equivalent experience.
• 5-7 years industry experience in Pharmaceutical industry or Medical device related (Quality, Regulatory, Labeling, Manufacturing) industry which includes at least 5 years of project management experience and part of those years of experience has 3 years of experience performing product or labeling change control responsibilities, with outstanding understanding and knowledge of the change control process.

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