Manager, Labeling

Edwards Lifesciences•Irvine, CA

1d•$118,000 - $167,000

About The Position

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Manager, Labeling position is a unique career opportunity that could be your next step towards an exciting future. How you will make an impact: Lead and manage demand for labeling operations activities, through collecting requirements, determining high level scope, justification, and rationale from concept through label release, including initiating and delivering to Operations labeling content and design changes. Assess business needs (e.g., portfolio specific labeling changes for BU product line), determine requirements, and provide labeling solutions in collaboration with BU stakeholders while establishing personal rapport and building sustainable relationships of trust through open and collaborative communications. Manage a small team within Labeling. Deliver labeling solutions per policies and procedures. Plan and direct assigned operational and/or project activities with the accountability for successful completion of assigned deliverables per priority mechanism. Drive labeling design and solution activities for product labels, instructions for use (IFU) and other forms of regulated labeling materials. Educate, train, and guide stakeholders to provide accurate information in support of successful labeling changes and new label development. Sustain production flow by monitoring process, providing input and reporting on performance metrics. Resolve design operations problems by analyzing data, investigating issues; identifying, recommending and leading the implementation of solutions. Develop team members to increase business acumen and functional skills. 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 less complex standardized solution development and best practices for labeling initiatives, including recommending and partnering with team members on activities involving legacy systems, process improvement, country-specific requirements, labeling standards and regulations. Evaluate risks and execute cost-effective labeling approaches to resolve critical issues Optimize labeling standards within assigned BU Develop report on demand and forecast labeling changes for assigned BU Other incidental duties

Requirements

Bachelor's Degree in a related field and experience in Labeling OR equivalent work experience based on Edwards criteria

Nice To Haves

Master's Degree or equivalent in a related field and experience working in a regulated industry
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
Extensive understanding of Labeling procedures while defining team operating standards and ensuring essential procedures are followed based on knowledge of own discipline
Knowledge of financial mechanism that relates to Labeling
Demonstrated skill set 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
Primarily interacts with internal subordinates and other supervisors
Typically interacts with external suppliers, vendors and/or customers
Share information and provides basic problem solving solutions; gains cooperation of others, conducts presentations of technical information concerning specific projects or schedules
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.
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

Responsibilities

Lead and manage demand for labeling operations activities, through collecting requirements, determining high level scope, justification, and rationale from concept through label release, including initiating and delivering to Operations labeling content and design changes.
Assess business needs (e.g., portfolio specific labeling changes for BU product line), determine requirements, and provide labeling solutions in collaboration with BU stakeholders while establishing personal rapport and building sustainable relationships of trust through open and collaborative communications.
Manage a small team within Labeling.
Deliver labeling solutions per policies and procedures.
Plan and direct assigned operational and/or project activities with the accountability for successful completion of assigned deliverables per priority mechanism.
Drive labeling design and solution activities for product labels, instructions for use (IFU) and other forms of regulated labeling materials.
Educate, train, and guide stakeholders to provide accurate information in support of successful labeling changes and new label development.
Sustain production flow by monitoring process, providing input and reporting on performance metrics.
Resolve design operations problems by analyzing data, investigating issues; identifying, recommending and leading the implementation of solutions.
Develop team members to increase business acumen and functional skills.
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 less complex standardized solution development and best practices for labeling initiatives, including recommending and partnering with team members on activities involving legacy systems, process improvement, country-specific requirements, labeling standards and regulations.
Evaluate risks and execute cost-effective labeling approaches to resolve critical issues
Optimize labeling standards within assigned BU
Develop report on demand and forecast labeling changes for assigned BU
Other incidental duties