Senior Manager, Labeling

Imagine how your ideas andexpertisecan change a patients life. Our GlobalOperations &Qualityteam plays a central part in ensuring our products are delivered to patients with cardiovascular disease.Youllpartner cross-functionally with manufacturing operations and sales teams delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning labeling warehouse management material handling or any of our other supply chain opportunities you will be making a meaningful contribution to our team and to patients all over the world.

Key Responsibilities:
Provide labeling leadership and product solutions to address business needs including leading initiatives across one or more BUs and labeling areas driving capacity and demand planning for change requests that are aligned with BU-driven prioritization in collaboration with stakeholders. Manage and oversee the work of a Labeling team and may indirectly manage cross functional or matrix teams. Drive labeling design and solution activities for product labels instructions for use (IFU) and other forms of regulated labeling materials
Create assigned standardized documentation and processes. Own and lead the execution of process control within assigned scope utilizing quality metrics. Identify opportunities and lead the implementation of changes to drive improvements within assigned BU
Manage activities with the accountability for successful completion of assigned Labeling deliverables. Identify risk develop mitigation strategies alternative solutions resolve issues action item follow up in collaboration with stakeholders. Educate train and guide stakeholders to provide accurate information in support of successful labeling changes and new label development
Develop a robust talent development plan in alignment with functional growth strategies of the department
Initiate root cause investigations for labeling operations driven non-conformances and CAPA investigations and ownership. Develop labeling operations metrics and lead the execution of operations quality initiatives
Drive standardized solution development and best practices for labeling initiatives including recommending and leading activities involving legacy systems process improvement country-specific requirements labeling standards and regulations. Evaluate risks identify alternatives and plan cost-effective labeling approaches to resolve critical issues
Optimize labeling standards across the BU
Develop reports on demand and forecast labeling changes for BU
Other incidental duties

Education and Experience:
Bachelors Degree in in related fieldrelated experience in Labeling Required and
Demonstrated track record in people management Required
Masters Degree or equivalent in in related fieldExperience working in a regulated industry Preferred

Additional Skills:
Proven successful project management leadership skills
Proven expertise in Microsoft Office Suite and related tools and systems
Excellent problem-solving organizational analytical and critical thinking skills including high discretion/judgment in decision making
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Expert understanding of Labeling procedures while addressing issues with impact beyond own team based on knowledge of related disciplines
Expert understanding of related aspects of Labeling processes and/or systems
Ability to build sustainable relationships of trust through open and collaborative communications
Knowledge of financial mechanism that relates to Labeling
Demonstrated ability to manage assigned team and provide coaching and feedback including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value to the business
Strict attention to detail
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Adherence to quality system global and regional Labeling standards and regulations Ability to work and excel within a fast paced dynamic and constantly changing work environment
Frequently interacts with customers and/or functional peer group managers normally involving matters between cross-functional teams and the company; often leads a cooperative effort among members of a project team
Participate and present at meetings with internal and external representatives
Resolve operational and scheduling issues
Dedicated to quality client service and pro-active and responsive to client needs.
Develop peer cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
Develop relationships and leverage them to influence change
Support and solicit input from team members at all levels within the organization
Adhere to all company rules and requirements (e.g. pandemic protocols Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control