Manager, Traceability & Labeling Controls

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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

• Excellent analytical skills on understanding data and data analysis leading to innovation in addressing patient safety, experience, accessibility and delivering value beyond compliance.

• Experience with managing and enhancing systems used in regulatory compliance such as Serialization, UDI, GDS and systems managing GS1 assets including GxP validation.

• Excellent communication skills (written, oral and presentation).

• Ability to develop relationships and inspire confidence and trust from internal and external partners at all levels.

• Strong understanding of new age digital technologies (blockchain, Cloud services, RFID), life sciences industry, consumer goods industry, and supply chain processes in a regulated environment.

• Digital product management experience.

• Strong management skills to lead and develop team members and influence others in a complex matrix organization 

• Experience with industry standards such as GS1 (Global Standards organization) and technologies such as Azure Cloud

• Understanding of end-to-end supply chain interactions, interdependencies, and end-to-end business/IT architecture.

• Ability to understand the cultural and change management requirements and impact inherent in a large, complex organizational change initiative

• Experience with making data-informed decisions, with concrete examples of outcomes resulting from defining and measuring success.  

• Comfortable with leading multiple projects/initiatives.

Other:

This position is hybrid and preferably located in New Jersey (New Brunswick office) with consideration given to other J&J sites located inside of the US. The position may require up to 20% domestic and international travel.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

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