Job Description

　　The Labeling Manager is a key leadership position within our Labeling group in Irvine. This strategic role will manage a team of 8 people, lead labeling design efforts as well as working cross-functionally in close partnerships with other teams, both in Irvine and globally. This role requires the ability to leverage technical knowledge of systems, processes, and regulations as well as have a clear understanding of end-to-end process to drive labeling solution and strategy globally.

　　Key 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; and 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

　　Minimum Qualifications:

　　• Bachelor's Degree and related Labeling experience

　　Preferred Skills:

　　• Master's Degree and 6-8 years of related Labeling experience

　　• Experience working in medical device, pharmaceutical or FDA 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

　　Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

　　For California, the base pay range for this position is $106,000 to $151,000 (highly experienced).

　　The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

　　Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

　　COVID Vaccination Requirement

　　Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.