Protecting our tomorrow

Job Title: North America Serialization, Systems, & Compliance Manager

Location: US Remote; East Coast Preferred

Department: Supply Chain

Reports To: Senior Director, Head of North America Supply Chain

Salary Range: $120k - $155k

Position Overview

We are seeking an experienced Manager to manage vaccine serialization, systems and compliance in our North America Supply Chain.  You will focus on managing day-to-day operations, while also supporting to identify and implement strategies necessary for the North America Supply Chain across these three areas to enable business continuity.  This role requires a deep understanding of US and Canada vaccine industry serialization & compliance related regulations/ requirements/ best practices/ operational process, EPCIS & EDI data exchange, master data management & operations, and digital & ERP operations.

Key Responsibilities

• Act as the main point of contact in the North America Supply Chain related to all serialization, supply chain systems, EDI, master data, & compliance topics for US & Canada
• Monitor and manage day-to-day activities related to US & Canada serialization/ ERP/ EDI transactions, and compliance and assist in resolving issues in the supply chain to ensure business continuity, collaborate with internal/ external local & global partners (i.e. 3PLs, wholesaler/distributors, outside vendors, internal company stakeholders, etc.) on resolution of issues, escalate issues to the appropriate functions when needed
• Ensure adherence to quality standards by managing documentation, maintaining data integrity, conducting risk assessments, change control management, ensuring compliance with relevant regulatory requirements across the North American Supply Chain, ultimately prioritizing patient safety and product efficacy
• Provide support and issue resolution to processes around serialization/ERP/EDI, propose strategic solutions to technical problems and compliance issues, and be a supportive team to implement process improvement to streamline operations
• ·Liaison with business partners to understand emerging requirements around serialization/ERP/EDI, compliance and provide support
• Support and coordinate with global supply chain on US & Canada technical readiness and provide technical support for all ongoing compliance activities to meet future requirements in the region
• Business continuity planning & quality risk management: oversee and help to develop business continuity plans and product lifecycle risks to help build a resilient audit-ready supply chain. Proactively identify necessary changes in the North America Supply Chain to keep up with evolving market & compliance requirements
• Responsible for driving achievement of targets from a compliance perspective, from GxP, training & SOPs for the North American Supply Chain
• Master Data: Oversee North America Supply chain governance, stewardship, and maintenance of crucial data elements, ensuring alignment with standards

Qualifications

• Bachelor’s degree in supply chain, Engineering, IT, Business Administration or a related field 

• A minimum of 5 years’ experience within vaccine/ pharmaceutical supply chain encompassing areas of serialization (especially US DSCSA), ERP, EDI, and compliance in US & Canada

• Knowledge of cGMP and GDP applications 

• Experience working in cross-functional and multicultural organizations 

• Understanding and experience in master data management & governance 

• Previous experience with implementation of serialization, ERP, EDI solutions 

• Strong systems connectivity skills, including experience establishing connections with 3PLs and integration to ERP.

• Previous experience with working supply chain platform vendors that provide serialization & EDI services (i.e TraceLink, TrueCommerce, etc) 

• Previous experience working with 3PLs, wholesaler/distributors 

• Ability to manage operational tasks 

• Effective and proactive problem-solving skills

• Strategic thinking capabilities 

• Excellent verbal and written communication skills

• Experience using tools such as Dynamics 365, iContracts, supply chain platform solutions

• Strong organizational skills and documentation skills, managing follow-up, and tracking request trends month over month