Integra Lifesciences Holdings Corporation Plainsboro , NJ 08536
The Marketing Operations Labeling Process Leader is responsible for designing, driving, and implementing the overall labeling process across all labeling sites and oversees a suite of global systems which support Integra's global labeling process. Collaborates with cross-functional partners and key stakeholders in Marketing, Regulatory, Quality Assurance, R&D and Global Operations to help define and develop enterprise level labeling strategies and execution plans to ensure consistent operations across all sites. The Labeling Process Leader works closely with partners in Quality Assurance, Global Operations, and IS/IT to continue the roll-out of the Integra global labeling process at legacy sites as well as acquisitions, ensuring appropriate linkages between the global quality system, site quality systems, IS/IT infrastructure, and label artwork development teams.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Design, develop, and enhance global labeling processes to ensure consistent label execution across all internal and external manufacturing sites. Includes linkages and handoffs between global shared services groups and local manufacturing, both Integra-managed and OEM.
Proactively identify and champion process improvements and systems enhancements to consolidate labeling processes under the enterprise labeling procedure.
Lead the development of a comprehensive postponed labeling strategy, enabling centralized control and consistent execution of market-specific labels throughout the distribution network.
Become labeling subject matter expert and serve as single point of contact for labeling process and system questions and issues. Work closely with partners in IS/IT, QA, and the global labeling team to ensure swift and timely resolution labeling inquiries.
Lead strategic process improvements to support Integra's evolving manufacturing, distribution, and QA model.
Standardize global labeling team activities to align with manufacturing site requirements. Align label development work with engineering, R&D, and procurement requirements.
Oversee label system implementation at legacy Integra sites and future acquisitions. Includes system design based on unique site requirements, driving adoption of global systems, label artwork migration, and serving as business lead for system validation and change control.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
Bachelors degree is required
5-8 years of experience, ideally in medical device or pharmaceutical labeling development and management
Knowledge of medical device industry barcode trends and requirements
Complete understanding of manufacturing requirements for medical device labeling
Excellent attention to detail
Strong organizational and project management skills
Ability to acknowledge issues or problems and work quickly to identify solutions
Knowledge of graphic design processes and software is a plus
Knowledge of core Microsoft Office software including Word, PowerPoint, Excel and Project
Aptitude for learning new software and systems
Ability to lead and collaborate well with cross-functional business partners across a large matrix organization