Manager, Labeling Operations

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary:

The Labeling Manager leads a team of Project Leaders and Graphic Designers to support Medical Products and Therapies (MPT) segment, ensuring that labeling is completed within the committed timelines. The Manager also has the accountability of communicating regularly with regional based labeling stakeholders and the Graphic Designer team to ensure labeling production timelines are maintained. This role will also ensure 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 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 and Graphic Designers. Manages overall coaching, training, development for direct reports.

•  Collaborates with multi-functional Subject Matter Experts (SMEs) to ensure all required inputs are identified and compiled for labeling changes. Ensure 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, Regulatory Affairs, Supply Chain, Manufacturing, Quality, Packaging, Material Suppliers, and Third-Party/CMO companies.

Qualifications:

• Must have thorough knowledge of the labeling printing processes at suppliers and in the manufacturing process.

• Is organized, has an 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 other’s 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/or Experience:

• Bachelor level degree or equivalent experience

• 5-7 years industry experience in Pharmaceutical 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.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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