【Alexion Japan】Associate Director, NPI Lead

This is what you will do:

This is a key position within Global Supply Chain team in Alexion. The key activities of the role are to work side by side with and under theguidance of the Supply Chain Director in Japan, work out for strategy and various business initiatives andprojects. This role will have direct responsibility for new product introduction,and all supply chain planning and it’s strategic initiative for Japan.

This role involves responsibilities to execute professional activities under clear strategy and the necessary collaboration for the entire team to be successful. It is also required to facilitateand establish strong relationships and collaborate with all key stakeholders across the Alexion global network.

You will be responsible for :

• Lead cross-functional NPI/Supply Chain projects within Japan OPS, supporting CMC, PDCS, GOLT, ATO and GSC 

• Prepare for launch of new products, ensuring execution of cross functional, interdependent tasks are complete on time for Launch milestones (PPQ, JNDA, PAI, Approval & Launch). 

• Keep the GOLT updated on progress and issues and work collaboratively to ensure no delays to Launch timelines.

• Schedule supply related milestones and activities, including post launch BAU handoff to the local supply chain team.

• Ensure DP importation plan executable to support PDCS/AOLT qualification activities.

• Responsible for Local Artwork creation and maintenance, including required approval from internal/external stakeholders. 

• SKU creation and SAP set up, including material master data, ensuring that global master data rules are followed and the system is tested to ensure no issues executing tasks.

•  Confirmation and execution of Tax, Financial and Physical flows.

•  Ensure IQ/OQ/PQ and PV planning and execution complete and interdependencies are understood across the various functions.

• Ensure Drop/vibration/transportation test planning & execution.

•  Arrangement of samples requested by relevant stakeholders, ensuring sampling plan is clearly documented.

•  Establishing and leading site NPI/Supply Chain project teams in accordance with the AXN PM Framework. delivering project objectives efficiently and effectively

• Support to create and review Contract/SoW in collaboration with Global team.

• Continuously reviews plan execution against target. Proactively identify potential risks, issues andopportunities, developing alternatives, balancing business needs and costs, and ensure key contributors andstakeholders are fully aware of changes and developments.  

• Escalates when decision rights exceedestablished boundaries.

• Monitor and analyze the demand forecast and actual supply performance ina timely basis, and communicate with relevant stakeholders to confirm the gap, if any, between forecast and actual performance.

• Respond to questions and requests from domestic and international stakeholders.

• Effectively and efficiently manage project and strategic initiatives as assigned by Supply Chain Director Japan, and deliver on timelines and tasks as required and in accordance with project dates.

• Ensure the highest adherence to all compliance requirements within the function such as Good Distribution Practice (GDP Guidance)  and Change Control.

You will need to have:

• Previous Pharmaceutical Experience in Supply Chain essential and/or CMC/PDCS

• Have experience of launching products in a pharmaceutical industry.

• Working across various functions in product launches a distinct advantage.

• Experience in Supply chain planning, and leading and coordinatingcross functional teams for new product introduction.

• Experience in CMO management or production planning desired, including management of packaging campaigns and artworkmanagement

• Ability to negotiate stake holders and to manage multiple taskssimultaneously

• Knowledge of SAP or other ERP system

• Excellent communication and relationship building skills

• Strong process improvement and project management skillset

• Ability to lead and take initiatives, and to drive change

• Strong computer literacy, with MS Office (Word, Excel, Outlook, Power point)