Sr Governance Labeling Manager

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Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

Detail Oriented
Continuous Learner
Courageous
Collaborative
Critical Thinker
Influential

Sr Governance Labeling Manager

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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.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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Address

Explore this location Triq San Giljan
San Gwann
SGN3000
Malta Explore This Location

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

“I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need.”

Meet Lorena, Senior QA Associate in London, UK

“I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety.”

Meet Gary, Quality Research Manager in Singapore

“I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission.”

Join Our Talent Community

We're grateful for your interest in a career with Baxter, and would like to get to know you. Joining our Talent Community is a great way to stay connected, learn more about Baxter, and help our recruiters find you if there's an opportunity that aligns with your background, skills and interests.

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Sr Governance Labeling Manager

Overview

Success Profile

Sr Governance Labeling Manager

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Hear from Our Employees

Meet Christelle, Senior Quality Manager in Malta

Meet Lorena, Senior QA Associate in London, UK

Meet Gary, Quality Research Manager in Singapore

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Join Our Talent Community