The Role
Department
Reporting to the Senior Director, Supply Chain, US Warehouse and Logistics, the Manager, US Warehouse and Logistics will oversee the 3PL warehouse operation and supports Genmab’s Qualification and Validation activities.
This role works with Quality Assurance to maintain GXP compliance throughout the warehouse and distribution network. This includes quality events handling support investigations of quality events, external notifications and complaints, determine root causes, implement CAPAs, and drive closure.
Contribute to FDA Reporting and Inspections. Support the maintenance and operations of Genmab key supply chain systems such as ERP and serialization.
Key responsibilities include :
Oversee warehouse operation and distribution at 3PL and perform necessary Inventory management activities related to returns / destructions / recalls, change controls, deviations, CAPA’s, external notifications and complaints see below.
Work closely with 3PL to influence, advise, and coordinate operational efforts across their warehouse operation.
- Lead the GXP vendor management compliance activities. Vendor onboarding, vendor evaluation, and GXP operational meetings with vendor.
- Support shipping validation and qualification of new packaging materials at 3PL.
- Support the maintenance and operations of Genmab key systems such as ERP (SAP) as well as integration with 3PL and Serialization (Tracelink).
If needed, support implementation of enhancement testing and validations.
Work with Quality Assurance to maintain GXP compliance throughout the warehouse and distribution network. This includes quality events handling support investigations of quality events, external notifications and complaints, determine root causes, implement CAPAs, and drive closure.
Manage and maintain GXP documentation, data and procedures in Document Management system. Manage Recalls according to Genmab procedure.
Prepare data for Quality Management Reporting and Annual Product Quality Review.
Requirements - what you must have
- Technical or technically oriented degree level, e.g. within engineering, technical operations, logistics or supply chain management.
- Minimum of 5+ years of working experience including experience with process and shipping validation for temperature-sensitive products.
- Experience within a global and controlled environment.
- Ability to travel overnights for business, estimated at 1-2 times per calendar quarter, total of 4-8 times per year.
Where you will work
This role will report to the Princeton, NJ office, and is hybrid.
For US based candidates, the proposed salary band for this position is as follows :
$91,.00 $,.00
The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location.
Also, certain positions are eligible for additional forms of compensation, such as bonuses.
About You
- You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
- You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
- You are a generous collaborator who can work in teams with diverse backgrounds
- You are determined to do and be your best and take pride in enabling the best work of others on the team
- You are not afraid to grapple with the unknown and be innovative
- You have experience working in a fast-growing, dynamic company (or a strong desire to)
- You work hard and are not afraid to have a little fun while you do so
Locations
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance.
Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories.
Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.