Job Summary
The Serialization Manager will drive compliance to Drug Supply Chain Security Act (DSCSA) for the Market Unit in the US for Fresenius Kabi. They will collaborate effectively with functional leaders and stakeholders to ensure processes are up to date with the regulation, and ensure that any issues are handled and communicated in a timely manner.
• Salary Range: $128,000 – $133,500
• Position is eligible to participate in a bonus plan with a target of 10% of the base salary
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Read more about our benefits here.
Responsibilities
- This person will stay informed about updates and changes to Drug Supply Chain Security Act (DSCSA) regulations and ensure adjustments to serialization processes are completed in a timely manner
- Develop, own, and maintain processes for US supply chain serialization
- Develop and communicate compliance metric for serialization
- Manages exceptions resolution processes and reporting
- Oversee the connection and strategy between manufacturing, distribution centers, and customer service for inbound and outbound serialization issues
- Coordinate and manage SAP enhancement project requirements related to serialization
- Coordinate onboarding new customers to GS1 Electronic Product Code Information Services (EPCIS) and facilitate any testing/troubleshooting
- Facilitate and coordinate new product Drug Supply Chain Security Act (DSCSA) exemption status with relevant teams and ensure final decisions
- Communicate new product or existing product Drug Supply Chain Security Act (DSCSA) exemption status changes both internally and externally
- Support TPM (Third Party Manufacturing) team during onboarding of new CMOs (Contract Manufacturing Organization) (validating, coordinating, and performing dummy run protocols, label validation)
- Supports and initiates any suspect and illegitimate product investigations as needed
- Facilitates completion of all Illegitimate Products notifications through the 3911 platform with the Drug Supply Chain Security Act (DSCSA)..
- Creates and conducts Drug Supply Chain Security Act (DSCSA) awareness trainings as needed
- Lead audit trail process through resolution
- All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities
Does NOT manage other employees.
Requirements
·Bachelor’s degree in a relevant field such as pharmaceutical sciences, engineering, or supply chain management is required.
·Minimum of 8 years of experience within Supply Chain industry.
·Strong communication and interpersonal skills, with the ability to collaborate with stakeholders at all levels of the organization.
·Demonstrated experience in pharmaceutical distribution or related industries, with a strong understanding of serialization requirements and processes
·Excellent project management skills, with the ability to prioritize tasks, manage timelines, and lead cross-functional teams effectively
·Leadership qualities with the ability to motivate and inspire team members to achieve serialization objectives
·Problem-solving skills with the ability to address challenges and make data driven decisions to optimize serialization processes.
·Knowledge of Microsoft Office Suite including Project.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
