Global Standards Programs Manager

1 month ago

Waukegan, United States Abbott Full time

The Opportunity

As a Global Standards Programs Manager , you will be the Subject Matter Expert (SME) for the adoption and implementation of global data standards,. This role provides technical and process guidance and leadership on the adoption and implementation of these standards across all business units and products. This ensures compliance with regulatory and customer requirements, such as those from regulatory bodies, healthcare providers, retailers, and commercial partners.

The Senior Consultant coordinates and leads major cross-divisional, multi-country initiatives to address industry and compliance requirements. They maintain relationships with key internal leaders (such as those in Regulatory, Supply Chain, Customer Service, and Customer Master) and external organizations (including standards organizations, regulators, and industry associations) to collaborate with and influence these stakeholders in the adoption and implementation of standards.

What You’ll Work On

This position reports to the Director of Tracability, Planning and Wharehousing.

Main Responsibilities:

Program Management for GS1 and UDI related activities – US FDA UDI Rule, EU MDR/IVDR, and emerging UDI requirements around the globe. Responsible for overall successful implementation of GS1 Standards across divisional/global boundaries – barcoding, UDI regulation. This position will function primarily through influence rather than authority. The position will interact with multiple levels across the Enterprise and will be required to hold the organization accountable for implementation of GS1 and UDI-related regulations and requirements. Responsible for the implementation of training and education plans that keep the entire supply chain audience up-to-date on GS1 standards and in compliance with approved policies and procedures around GS1 standards. Ensure compliance with applicable Corporate and Divisional policies and procedures. Accountable for program budget spend and timely deliverables. Performs related duties as assigned or requested by director of tracaility, planning and wharehousing.

Strategic Focus

Communicate GS1 stratgies to business and IT Provide strategic consultancy support for GS1 standards defining or designing business processes and requirements. Research and identify enabling solutions, best practices, and technologies to proactively address customer requirements

Portfolio Management & Project Execution

Collaborate with BRMs to prioritize business IT initiatives. Manage and support IT project portfolios, ensuring alignment with enterprise IT strategy. Identify and manage business process improvements and decision-making support needs. Align business requirements with regional or global templates. Communicate project progress, changes, and milestones effectively. Ensure adherence to best practices, standards, and guidelines. Assist in tracking benefits post-implementation. Align IT demand and supply with business needs and oversee related IT initiatives. Plan, control, and monitor projects, managing resources to meet objectives. Ensure project success within defined constraints, focusing on both execution and business results.

Financial Accountability

Ensure Abbott’s annual contractual and financial obligations are met with global standards organizations. Indirect budget management may be required.

Training and Education:

Develop, implement, and maintain a comprehensive curriculum on global data standards and UDI compliance. Create and update training materials to meet current regulatory and industry requirements. Deliver training and educational content through various media formats. Ensure accessibility and effectiveness across different regions and learning preferences.

Stakholder Management:

Engage with global and regional standards organizations. Maintain and build relationships with staff, thought leaders, and supply chain partners; mentor junior staff. Foster internal relationships with senior staff and management across various departments, including Regulatory, Quality, Manufacturing Operations, Commercial, Customer Service, Supply Chain, and IT.

Required Qualifications:

Education : Bachelor’s Degree in Science or an equivalent combination of education and work experience. Experience : 10+ experience in the life sciences industry and 6+ years managing projects in life science or CPG industries.  Expertise: Knowledge of global labeling standards, including: GTIN: Global Trade Item Numbers, GLN: Global Location Numbers, GLN: Global Location Numbers, GLN: Global Location Numbers and barcoding standards Data Experience: Minimum of 2 years of regulatory experience with US FDA Unique Device Identification (UDI) requirements, EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) requirements or managing similar data compliance projects Strategic Skills : Proven strategic experience data management and data collection, particularly regarding emerging global regulatoryI database submission requirements. Leadership and Communication : Strong capabilities in relationship management, client management, and strategic thinking. Demonstrated ability to provide leadership for implementation guidelines and processes to ensure seamless transitions. Communication Skills : Experience in driving communications concerning implementation plans at the enterprise, divisional, and country levels. Ability to work and communicate effectively across international and cultural boundaries.

Preferred Qualifications

Deep understanding of global data standards and unique device identifications(UDI) compliance. Proven track record of GS1 standards expertise and be effective at applying/implementing requirements that support goals for regulatory partners and customers Familarity with regulatory requirements and industry best practices with experience in IT strategy, project management and business analysis Knowledge of supply chain management and quality assurance processes for life science and CPG industries. Excellent communication and interpersonal skiils to engage with global and regional standard organizations. Profiency in project management tools and methodologies or relevant certifications in project management (e.g., PMP) or IT governance Proficient with Microsoft Office tools (Visio, Excel, Word, PowerPoint, SharePoint, Outlook) Strategic thinker with the ability to align IT initiatives with business goals. Excellent analytical and problem soliving skills

Supervisory responsibilities:

Manage and mentor junior staff and contractors

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