North America Serialization, Systems & Compliance Manager
Apply NowCompany: Bavarian Nordic
Location: Durham Bridge, NB E6C 1A3
Description:
Protecting our tomorrow
Protecting Our Tomorrow
At Bavarian Nordic, we aspire to save and improve lives by developing innovative vaccines that are designed to unlock the power of the immune system. We are a global leader in smallpox/mpox vaccines, and our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, typhoid fever, and cholera. We excel in R&D innovation, manufacturing, and commercialization. We aim to improve health and quality of life for children and adults around the world - protecting our tomorrow. We hope that you will share this mission with us.
North America Serialization, Systems, and Compliance Manager
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, ERP & EDI, and master data management & operations.
Your Responsibilities
Skills & Requirements:
We offer
A chance to work in an international company with unique technology and a dedicated workforce. We welcome people who share our passion with a willingness to make a difference. We offer a dynamic and flexible work environment and an opportunity to develop both your personal and academic competencies. We offer a comprehensive benefits plan and a competitive compensation package.
Salary Range - $110k - $150k
Location: US Remote
Caught your interest?
If you are interested in the position, we look forward to receiving your application via our recruitment system. Just click the Apply-Button on the right side of the page and you will be redirected to our application form.
Founded in 1994, we have +30 years of experience developing life-saving vaccines. We are a global leader in smallpox and mpox vaccines. Our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America. Our values - our Bavarian Nordic DNA, as we like to call it - are what guide our actions every day. We act as persistent pioneers, embrace change, value being boosted by the team, and believe in protecting lives every day. If that is also a part of your DNA, we invite you to join us in Bavarian Nordic! 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.
www.bavarian-nordic.com
#LI-MA1
$93,600.00 - $140,400.00
Protecting Our Tomorrow
At Bavarian Nordic, we aspire to save and improve lives by developing innovative vaccines that are designed to unlock the power of the immune system. We are a global leader in smallpox/mpox vaccines, and our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, typhoid fever, and cholera. We excel in R&D innovation, manufacturing, and commercialization. We aim to improve health and quality of life for children and adults around the world - protecting our tomorrow. We hope that you will share this mission with us.
North America Serialization, Systems, and Compliance Manager
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, ERP & EDI, and master data management & operations.
Your 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 to IT 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
Skills & Requirements:
- 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
- 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
We offer
A chance to work in an international company with unique technology and a dedicated workforce. We welcome people who share our passion with a willingness to make a difference. We offer a dynamic and flexible work environment and an opportunity to develop both your personal and academic competencies. We offer a comprehensive benefits plan and a competitive compensation package.
Salary Range - $110k - $150k
Location: US Remote
Caught your interest?
If you are interested in the position, we look forward to receiving your application via our recruitment system. Just click the Apply-Button on the right side of the page and you will be redirected to our application form.
Founded in 1994, we have +30 years of experience developing life-saving vaccines. We are a global leader in smallpox and mpox vaccines. Our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America. Our values - our Bavarian Nordic DNA, as we like to call it - are what guide our actions every day. We act as persistent pioneers, embrace change, value being boosted by the team, and believe in protecting lives every day. If that is also a part of your DNA, we invite you to join us in Bavarian Nordic! 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.
www.bavarian-nordic.com
#LI-MA1
$93,600.00 - $140,400.00