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Labeling Manager

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Date: Aug 14, 2019

Location: Libertyville, IL, US

Company: Hollister Incorporated

We Make Life More Rewarding and Dignified

Location: Libertyville 
Department: Operations 

Summary:

Manage, streamline and standardize global labeling development processes, systems and procedures to ensure they are operating reliably, producing accurate labeling, and meeting medical device labeling regulations and Hollister standards for finished goods product labeling, as well as managing personnel performing such duties.  As a leader of people, competency and focus on overall team development is imperative for success in this position.

 

Provide oversight and assistance with implementation and understanding of department responsibilities: loading and maintenance of label elements and labeling requirements; maintenance of label templates, formats, artwork and label types; usage of appropriate barcodes; parsing of UDI label elements and maintenance of GTIN triggers; creation and maintenance of label data sets for each product SKU/label type; creation and release of finished goods product GLS labels for Production use; label review and approval circulation process; and understanding of Global UDI Solution maintenance and UDI submittal to government agencies (domestic and foreign). 

 

Contribute to Hollister’s growth, profitability, and continuity by leading global labeling initiatives for Hollister and Dansac products. Work with cross-functional teams, management and various company stakeholders to ensure timely creation and revision of labeling to meet forthcoming regulatory compliance requirements for product identification and traceability.

 

Responsibilities:

 

  • Manage and coach direct reports
  • Ensure timely and satisfactory completion of all labeling projects and initiatives pertaining to finished goods product labeling (GLS labels, label artwork, package artwork and documents) are met.  
  • Ensure compliance with (and monitor changes to) US, EU and ROW medical device labeling regulations, standards and guidelines; assuring required essential labeling elements (per country) are accounted for within finished goods product labeling.
  • Apply comprehensive knowledge, independently, on concepts, principles, and technical capabilities for projects of large scope and complexity
  • Collaborate with cross-functional management and stakeholders including Regulatory Affairs, Corporate Communications, IT, Packaging, Master Data, Supply Chain, Manufacturing, Distribution, Marketing, R&D, Quality and other departments as applicable.
  • Assures that provided labeling elements per SKU are loaded, configured and accounted for within the global labeling system to produce finished goods product labels as applicable per label request.
  • Own and maintain Global Labeling procedures to assure the integrity of product labels (domestic and foreign) for all products manufactured at or for Hollister, as well as responsibility of creation, oversight and revision of applicable Site labeling procedures.
  • Implement and manage qualification and/or validation of systems or equipment necessary for graphics or labeling.
  • Assist in establishing and meeting Labeling budget commitments.
  • Represent Hollister Incorporated at industry events (conferences, seminars, etc.)

 
Requirements:
 

  • Bachelor’s Degree in a scientific discipline required. Advanced Degree desired.
  • Industry certifications desirable
  • 8-12 years overall experience
  • Minimum of 8 years of healthcare industry experience.
  • Leader of people or teams
  • Experience with health industry or medical device labeling
  • Project management experience -or- Demonstrated leadership and mentor skills indicating management capabilities to meet or complete project deadlines, initiatives and schedules, as well as communicating and providing direction to team members.
  • Ability to build, work with, and strengthen relationships with team members in other departments, other Sites, Vendors and Contract Manufacturers; as well as extensive experience in leading and facilitating diverse teams, both face-to-face and in a virtual setting.
  • Proficient in understanding, interpreting, and applying US, EU and ROW labeling regulations for medical devices and general regulatory knowledge, as well as overall FDA, EU and OUS regulations.
  • Strong problem-solving skills; ability to analyze all aspects of a situation, challenge current methods, identify potential solutions, make informed decisions and implement the best solution in an efficient, timely manner.
  • Working knowledge of Hollister product, as well as Hollister labeling practices, procedures and systems:
    • Solid, functional understanding of departments’ needs, capabilities and system interfaces.
    • Software experience with Qumas, SAP, PXSmartPrint, Loftware, Veeva, Microscan, etc. is desired
    • Knowledge of printable packaging and labeling substrates and printing systems
  • Ability to analyze information quickly and make informed decisions
  • Clear, concise and effective oral and written communication skills
  • Strong organization skills and attention to detail
  • Experience with GS1 standards
  • Fluent in English
     


Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets products for ostomy care, continence care, and critical care and develops educational support for patients and healthcare professionals. We have been in business for more than 95 years. Our products are sold in more than 90 countries and we have manufacturing and distribution centers on three continents. At Hollister Incorporated, we are passionate about the work we do, and we are committed to making life more rewarding and dignified for our Associates and for the people who use our products and services. A career at Hollister Incorporated can take many paths, all of them leading to rewarding opportunities.

 

Hollister is an EO employer - M/F/Veteran/Disability

Job Req ID: 27574


Nearest Major Market: Chicago

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