Manager, Traceability & Labeling Controls

About this role

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Data Analytics & Computational Sciences

Job Sub Function: Business Intelligence

Job Category: People Leader

All Job Posting Locations: New Brunswick, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description: The Global Trade Controls (GTC) organization is recruiting a Manager Traceability & Labeling Controls in New Brunswick, NJ, with consideration given at the discretion of the business to other US based J&J site locations.

Job Description: The role oversees end-to-end project management, deployment and coordination for GTC T&LC platforms and programs including Serialization & Traceability, Unique Device Identification (UDI), Global Data Synchronization (GDS), GS1 standards and Digital Solutions (Digital Labeling). This position leads cross-functional and cross-sector teams to deliver compliant, scalable solutions that meet regulatory and customer requirements, embeds new processes into the base business for sustained support, and drives measurable improvements in data quality for internal and external customers.

Tasks / Duties / Responsibilities

• Lead cross-functional (JJT, Deliver, Data Management, Finance, Manufacturing, External Manufacturing, Logistics) and cross-sector (Innovative Medicine and MedTech) teams for enterprise program deployments and ongoing base-business support. • Own program and project delivery: scope, schedule, budget, quality, risk and stakeholder communications. Ensure country-specific activities follow the project charter and timeline. • Gather business inputs and requirements from cross-functional and cross-regional stakeholders to define and access business requirements for system-to-system connectivity, including data modeling and data mapping; engage with technology partners to develop solutions and roadmaps. • Prioritize portfolio for implementations, develop capital appropriation requests, plan approvals and drive regional/local engagement • Coordinate and provide business input to process design and requirements gathering (including KPIs) and user acceptance testing (scripts and test conduct). • Ensure integration of all supply chain stakeholders (internal sites, external manufacturers, third party logistic providers, customers) by collaborating with business/IT project managers, subject matter experts and stakeholders. • Lead technology development efforts, based on market requirement, in partnership with industry partners, associations, and internal stakeholders to deliver compliant solutions within the organization. • Engage appropriate stakeholders (regulatory, commercial and sectors) to interpret requirements and design future-state processes that ensure regulatory and customer compliance. • Identify and recommend technologies to improve operational processes, enhance data quality and meet customer compliance expectations. • Ensure work instructions and operational procedures align to GxP and other applicable quality standards. • Maintain program comprehensive metrics, manage issues, drive problem resolution and contingency planning, and report status to stakeholders and leadership.

Other Duties

• Develop playbook for on-going deployments and sharing best practices.  • Promote development, utilization and expansion of new product identification, serialization and traceability capabilities to meet regulatory requirements.  • Identify opportunities to leverage these capabilities to deliver value, to J&J and its partners, beyond compliance.  • Lead J&J’s efforts regionally and globally with regulators and industry groups to influence industry and regulatory authorities and shape regulations.  • Establish robust base business process after project closure.  • Support global leadership team in activities related to global strategy, tactical actions, and financial management for all digital solutions. • Represent T&LC team within the local business, IT, and supply chain organizations and external industry forums, standards organization, etc. • Develop, align with business, and execute opportunities to leverage these capabilities to deliver value to J&J and its partners, beyond customer compliance. • Keep abreast of new/existing regulations and pending regulations for other countries and new/existing customer requirements. • Lead J&J's efforts regionally and globally with industry (e.g., GS1, Pharmaledger, EFPIA etc.) to influence industry and regulatory authorities and shape regulations. • Work with Organizational Change Management and Communications team members to develop appropriate documents for internal and external stakeholders.  • Identify opportunities for value creation for the business and customers/partners; execute them as prioritized.

Required Minimum Education : Bachelor’s degree required

Required Years of Related Experience: 8+ years with at least 2-4 years in supply chain

Other: PMP certification or equivalent is preferred.   Required Knowledge, Skills and Abilities : • Experience with industry standards such as GS1 (Global Standards organization).  

• Experience with ERP/SAP data management systems and processes in a manufacturing/distribution environment

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