North America Serialization, Systems & Compliance Manager

Bavarian Nordic; Durham (NC); Remote; USD 120,000 - 155,000; Full time

Job summary

Bavarian Nordic seeks a seasoned North America Serialization, Systems, & Compliance Manager to lead serialization, ERP/EDI, and compliance within the NA Supply Chain. The role emphasizes US & Canada regulations, data integrity, and operational readiness.

You will drive day-to-day serialization/ERP/EDI activities, coordinate with 3PLs and vendors, and implement process improvements to ensure regulatory compliance and patient safety across the region.

Qualifications

• Bachelor’s degree in supply chain, engineering, IT, business administration or related field.
• Minimum 5 years’ vaccine/pharma supply chain experience including serialization (US DSCSA), ERP, EDI and US/Canada compliance.
• Knowledge of cGMP and GDP applications.
• Experience in cross-functional, multicultural environments.
• Master data management and governance understanding.
• Serialization/ERP/EDI solution implementation experience.
• Strong systems connectivity with 3PLs and ERP integrations.
• Experience with serialization/EDI service vendors (TraceLink, TrueCommerce).
• Experience working with 3PLs and wholesalers/distributors.
• Excellent organizational and documentation skills.

Responsibilities

• Act as the main NA Supply Chain contact for serialization, systems, EDI, master data and compliance for US & Canada.
• Manage day-to-day serialization/ERP/EDI transactions and compliance; collaborate with partners to resolve issues and ensure business continuity.
• Ensure quality standards via documentation, data integrity, risk assessments, and change control across NA supply chain.
• Support serialization/ERP/EDI processes; propose strategic solutions and drive process improvements.
• Liaise with partners to understand emerging serialization/ERP/EDI/compliance requirements and provide support.
• Coordinate with global supply chain on NA technical readiness and ongoing compliance activities.
• Oversee business continuity planning and quality risk management; adapt to evolving market and regulatory needs.
• Drive achievement of compliance targets (GxP, training, SOPs) in the NA Supply Chain.
• Oversee governance and maintenance of master data elements in NA supply chain.

Skills

Cross-functional teamwork

Problem-solving

Strategic thinking

Documentation

Project management

Education

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

Tools

Dynamics 365

iContracts

TraceLink

TrueCommerce

ERP systems

Job description

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

About Bavarian Nordic

Bavarian Nordic is a global vaccine company focused on helping to protect lives through innovative vaccines, public health partnership, and expanded access to disease prevention.

We work across emerging infectious diseases, travel health, and public health preparedness to help communities, healthcare providers, pharmacies, and health systems improve vaccine awareness, access, and delivery.

With a growing commercial portfolio and strong global partnerships, Bavarian Nordic is evolving how vaccines are supported across healthcare ecosystems — combining scientific innovation with customer engagement, education, and public health impact.

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, elevate 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

Why Join Us

Join a mission-driven global vaccine company at a pivotal stage of growth and evolution. At Bavarian Nordic, you’ll have the opportunity to help shape innovative commercial programs, support public health initiatives, and contribute to how vaccines are accessed across healthcare channels.

We foster a collaborative, entrepreneurial culture where cross-functional partnership, creativity, and impact are valued alongside scientific excellence.

Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

For more information, visit www.bavarian-nordic.com

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