Sr Governance Labeling Manager

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.

Essential Duties and Responsibilities

• Establish labeling best practices by driving cross-functional global integration and collaboration
• Chairs the Labeling Governance Boards, leading effective and productive meetings through pre-meeting stakeholder engagement, agenda setting, metrics and escalation reporting and high-level project management in support of on-going labelling initiatives and future improvements
• Lead cross-functional labeling escalation meetings, driving resolutions and holding stakeholders accountable
• Responsible for serving as direct supervisor for a team of Senior Project Leaders / Labeling Governance Leads.
• Lead development of Global Labeling standard work, guideline and training materials.
• Responsible for Global Labeling training standards, as well as coaching for performance-ensuring a unified and high competence level across the organization
• Investigates labeling quality issues, driving sustainable resolutions. Owns nonconformances and corrective action plans if issue is directly related to Global Labeling activities
• Collaborates with the Global Labeling Systems Team to ensure that processes and tools are leveraged and accurately utilized to capture data and measure the efficiency and effectiveness of the labeling process.
• Analyzes labeling metrics and data for overall health and trends, using the results to improve labeling and corresponding processes
• 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 is 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
• Support management in extended labeling initiatives
• Will perform other duties as assigned

Qualifications.

• 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
• 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 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
• 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
• 10 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

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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