James Haas Email and Phone Number
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Accomplished Director with a proven track record of successfully leading global initiatives and organizations. Effectively implemented tools and technologies that significantly reduced cycle times and minimized labeling errors across the life sciences, pharmaceutical, medical device, in vitro diagnostic (IVD), and consumer packaged goods sectors. Subject matter expert in packaging development, labeling content, and localization, consistently ensuring adherence to FDA regulations and international compliance standards. Expertise in regulatory requirements, cross-functional team leadership, and process enhancement has facilitated substantial results, generating over $1M annually in productivity and cost savings. By identifying areas for improvement, created innovative solutions to intricate challenges and established robust policies and procedures that meet compliance requirements. Leadership, operational strategy expertise, and commitment to continuous improvement effectively drive the optimization of organizational objectives. Enjoy mentoring, managing, and fostering collaborative relationships with as many as 30 team members and important stakeholders. Core competencies include:Product Labeling Operations | Strategy Development | Packaging | Packaging & Product Labeling Development | Operational Oversight | Organizational Development | Regulatory Labeling | Technical Direction | Regulatory Requirements | Quality Assurance | Process Improvement | Digital Workflow/Asset Management | Organizational Development | Service Management | Enterprise Software Implementation | Project Management | Strategic Business Planning | Globalization | Business Development & Growth | Product Commercialization Specialties: Packaging and Labeling development process improvement, Digital Workflow Implementation, Digital Asset Management, Packaging Engineering and Graphic Design (Labeling) management, Globalization, Localization & Translations, Organizational Development, Brand Security
Integra Lifesciences
View- Website:
- integralife.com
- Employees:
- 3881
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Director, Global Regulatory LabelingIntegra LifesciencesPrinceton, Nj, Us -
Principal ConsultantPackaging & Labeling Management Solutions Oct 2023 - Present• Provided expert guidance in packaging, labeling, and graphic design to optimize processes and improve quality.• Collaborated with clients on organizational development strategies to enhance their global presence.• Implemented digital workflow systems to improve operational efficiency and client satisfaction.
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Director, Global Product Labeling Operations, Packaging & TechnologySiemens Healthineers Apr 2016 - Oct 2023Forchheim, DeProvide strategic leadership for packaging and labeling development, process improvement, and new technology implementation. Collaborated with cross-functional teams to define product requirements, optimize packaging components, and ensure compliance with regulatory standards. By implementing a labeling improvement initiative and new packaging specification process, achieved cost savings opportunities and reduced re-registration fees, while maintaining excellent collaborative relationships with key functions.• Transformed and developed a Global Product Labeling Operations, Packaging and Technology organization to focus on labeling and packaging development, specifications, proofreading, supplier quality, process improvement, and identify/implement new technologies to optimize the management of packaging and labeling.• Lead the effort to create/improve the process for the development of country-specific labeling to ensure compliance with all country-specific requirements.• Successfully lead the timely completion of all BREXIT and IVDR (In Vitro Diagnostic Regulation) required updates to Siemens Healthineers packaging, including UDI /EUDAMED. • Directed all aspects of package and labeling project management, enforcing consistency and compliance with design and business requirements in all aspects of new design and design change projects, including planning, budgeting, staffing, scheduling, monitoring, and development of metrics which were used for process improvement initiatives. • Developed and implemented a new packaging drawing specification process that improved the labeling development process, optimize packaging components and provide cost savings opportunities for Supply Chain Management and Procurement while providing documented requirements for Supplier Quality. • Implemented a global Artwork Management and Packaging Development/Digital Workflow system. -
Senior Manager, Global Product Labeling And User DocumentationSiemens Jun 2015 - Apr 2016Munich, DeManage an organization responsible for the development of all labeling and content creation, including packaging and user documentation, for diagnostic reagent products. Enforced consistency and compliance with design and business requirements in all aspects of new design and design change projects, including regulatory, safety, quality and corporate branding. Collaborated with manufacturing, regulatory, commercial and R&D functions to define and document product requirements and specifications to guide staff in the development of accurate and compliant labeling.Enforced consistency and compliance with design and business requirements in all aspects of new design and design change projects, including regulatory, safety, quality, and corporate branding.Identified areas of process improvement along with identifying and recommending innovative technology-based solutions that provide improvements in quality, productivity and cost savings.Completed a labeling improvement initiative for all packaging to standardize designs, layouts and templates, update symbology and bring all labeling into full regulatory compliance. Resulted in providing consistency across product lines and reduced re-registration fees for the company. -
Principal ConsultantPackaging & Labeling Management Solutions Jun 2014 - Jun 2015Provide direction as a subject matter expert in the packaging, labeling, and graphic design industry. Assist customers in the areas of packaging, labeling and print management, organizational development, process optimization, quality improvement, globalization and the implementation of enterprise digital workflow, digital proofreading and asset management systems.
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Packaging & Labeling Management Director/Account Relationship Manager - Design2LaunchEastman Kodak Company Sep 2011 - Jun 2014Rochester, New York, UsIn my role as Packaging & Labeling Management Director at Eastman Kodak Company, I provided expert guidance to customers in optimizing processes, improving quality, and achieving cost savings through digital workflow systems. By partnering with Kodak Brand Protection Solutions, I also delivered anti-counterfeiting solutions for brand protection.• Directed customers in packaging, labeling, and digital workflow systems, resulting in $5M sales growth.• Implemented enterprise digital workflow systems, reducing cycle times by 50% and saving $1M annually.• Integrated software systems for labeling management, decreasing project duration by 40% and ensuring compliance. -
Sr. Manager, Global Packaging, Labeling & Graphic DesignBausch + Lomb 2008 - Sep 2011Bridgewater, Nj, UsLed a global team managing the development of Packaging, Labeling, and Graphic Design for pharmaceutical (including OTC), medical device, and consumer goods, as well as marketing and sales materials. I optimized processes, reduced costs, and increased customer satisfaction through innovative technology solutions.• Transformed and led the growth of the Packaging Services group (600% growth) into the Global Packaging, Labeling & Graphic Design organization, overseeing all packaging and labeling worldwide.• Implemented a global Digital Workflow System, reducing cycle times by 50% and saving over $1M annually.• Collaborated with Regulatory Affairs in the development and maintenance of CCDS and English Masters (USPI and SmPC).• Decreased production downtime by 20% and reduced annual scrap costs by $300K by creating the packaging specification development and approval process. New procedure insured optimal design and compatibility with production. Process has been implemented at all global manufacturing sites and centrally controlled through a digital workflow system. • Implemented a new CAD system and integrated the new software with Adobe Illustrator allowing us to produce electronic mock-ups and virtual reality presentations. Reducing the need for physical sample making resulted in a cost savings of over $240K annually.• Developed and implemented the Global Policies and Procedures for the creation, translation, approval and control of Labeling that is followed on a global basis. Procedures ensure compliance with all labeling guidelines and global regulatory requirements. -
Manager, Global Graphics ManagementBausch + Lomb 2003 - 2008Bridgewater, Nj, Us• Managed the development and approval of packaging graphics (labeling) for globally marketed products. • Created a global process to accommodate both medical devices and pharmaceuticals after the acquisition of the Pharmaceutical and Surgical divisions. Integrated three distinct systems resulting in increased process and team efficiency, improved graphics quality, and produced a $1M annual cost savings through resource optimization and centralization. -
Section Manager, Packaging ServicesBausch + Lomb 1999 - 2001Bridgewater, Nj, UsEstablished the Packaging Services group in order to incorporate the graphic development function into the packaging engineering organization. Created a streamlined, efficient process for the development and distribution of primary and secondary packaging components. -
Senior Packaging EngineerBausch + Lomb 1997 - 1999Bridgewater, Nj, UsDeveloped and processed specifications for primary and secondary packaging for sunglasses, contact lenses, contact lens solutions, and accessories. • Began the creation of a new department that would be responsible for the development of packaging and labeling.
James Haas Skills
James Haas Education Details
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Rochester Institute Of TechnologyInformation Technology And Packaging Science -
Rochester Institute Of TechnologyPackaging Science -
The Levinson InstituteExecutive Leadership Development
Frequently Asked Questions about James Haas
What company does James Haas work for?
James Haas works for Integra Lifesciences
What is James Haas's role at the current company?
James Haas's current role is Director, Global Regulatory Labeling.
What is James Haas's email address?
James Haas's email address is ja****@****cox.net
What schools did James Haas attend?
James Haas attended Rochester Institute Of Technology, Rochester Institute Of Technology, The Levinson Institute.
What are some of James Haas's interests?
James Haas has interest in Children.
What skills is James Haas known for?
James Haas has skills like Packaging, Pre Press, Medical Devices, Cross Functional Team Leadership, Packaging Engineering, Process Improvement, Iso 13485, Graphics, Project Management, Management, Supply Chain, Lean Manufacturing.
Who are James Haas's colleagues?
James Haas's colleagues are Dr. Angel Melendez, Myrna Espiritu, Jean-Christophe Giet, Orlando Vargas, Carole Moran Mbs, Sameer Khaliq, Satyan Panda.
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