Labeling Governance Lead / Sr Labeling Project Leader

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.

Labeling Governance Lead

• Lead development of Global Labeling standard work, guideline and training materials
• Facilitate, lead and drive alignment across global cross-functional teams
• Support in resolving labeling pain points, identifying opportunities and driving labeling efficiencies
• Participate in labeling integration as also labeling digitalization initiatives by ensuring labeling team user requirements are met, support testing, provide documentation
• Support labeling compliance, participate in Change Control Governance activities, lead and document labeling investigations and develop sustainable corrective actions
• Empower labeling teams and stakeholders to be successful by coaching and setting up communication channels that allow easy knowledge sharing
• Interact and communicate with Baxter leadership as well as with the broader community
• Support management in extended labeling initiatives

Sr Labeling Project Leader

• Responsible for owning, managing and monitoring multiple moderate to complex labeling projects from initiation through completion
• Develops and writes a project scope summary description and rationale based on the labeling request’s scope and requirements
• Determine execution strategy in change management system
• Develop change plans activities and monitor activity closure
• Create and manage schedules to track projects to service level agreements
• Interact with global manufacturing plants to implement labeling on product
• Collaborate with global stakeholders to drive projects to completion
• Facilitate meetings to resolve project conflicts
• Monitor and control projects throughout the project lifecycle to mitigate and eliminate risks, resolve issues, schedule delays and resource constraints
• Collaborate with the gathering of data for metric purposes as assigned

Qualifications:

• Strong interpersonal and negotiation skills, pragmatic approach and hands-on attitude
• Ability to interact and adapt communication effectively with and to different levels of the organization
• Excellent written and verbal communication skills. Proficient in English.
• Critical, analytical thinking, problem solver
• Exceptional organizational skills
• Demonstrated self-starter who5 can quickly and efficiently manage continuous change; willing to challenge the norm when needed and drive to decisions
• Ability to lead global cross-functional team meetings
• High energy and innovative mindset
• Proficient use of Microsoft Office Tools (Word, PowerPoint, Excel, PowerBi, Visio, Project)
• Knowledge of change management systems preferred
• Experience with medical device and/or pharmaceutical labeling processes and systems a plus

Education/Experience:

• Bachelor’s degree in in Science, Engineering or related field
• Minimum of 5 years of experience in Quality, Manufacturing, R&D or related field, preferably in a global environment in pharmaceutical labeling or regulated industry
• Experience in quality assurance, compliance or quality systems management is a plus
• Experience in creating and maintaining project deliverables is a plus

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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