Senior Manager, Labeling

Edwards Lifesciences Gruppe; Kuala Lumpur; On-site; MYR 120,000 - 240,000; Full time

Job summary

Edwards Lifesciences is seeking a labeling operations leader to drive design, development, and compliance of product labels and IFUs. You will manage a labeling team, coordinate with cross-functional stakeholders, and implement process improvements in a regulated environment.

The role emphasizes leadership, regulatory understanding, and collaboration with BU teams to ensure timely labeling changes and quality outcomes.

Qualifications

• Bachelor's degree in related field required.
• Demonstrated track record in people management required.
• Experience in labeling in a regulated industry preferred.

Responsibilities

• Provide labeling leadership and drive design/solutions for product labels and IFUs.
• Create and own standardized documentation and process controls.
• Lead risk identification, mitigation strategies and CAPA for labeling operations.
• Develop and implement labeling standards and regulatory-compliant practices.
• Generate labeling change reports and support cross-functional teams.

Job description

Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner 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: Bachelor's Degree in in related fieldrelated experience in Labeling Required and Demonstrated track record in people management Required Master's 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 elevate 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

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.