Deputy Director, International Customer Service & Compliance Leader - Vaccine

The position will be responsible for the International Customer Service (ICS) and shipment logistics administration / coordination functions for all Commercial and Non-commercial order management processes for SWR products and product samples shipped internationally.

This includes all customer master data, order creation / management thru order fulfillment and customer communication regarding order status and delivery.

This group will provide key customer and shipment information to the transportation group to ensure readiness for transportation execution to meet customer delivery.

They will also be responsible to utilize and update appropriate tools (Loops, etc.). The position will also be responsible for all operational quality / compliance related activities for all functions in the Industrial Operations Materials Management Department (Deviation management, CAPAs, CCs, procedural and document updates, etc).

This position will report to the Sr. Director, Materials Management, will sit on the MM leadership team and will manage / direct a team of customer service and compliance managers.

This position will play a critical role in both site and global supply chain initiatives, ensuring all department operations are performed in a compliant manner.

Key accountabilities

Materials Management Quality Operations Compliance :

• Ensure, along with department / area leaders, all material management depts. operate in compliance with all applicable GMP and SOP / SWI work procedures and instructions (Warehouse & Logistics Operations, SAP Systems, Product Line, Operations Planning, etc.)
• Ensure all dept. training modules and documents are current and revised as needed. Coordinate compliance with the area training and document coordinators.
• Responsible to maintain required training and ensure the key team members maintain required training and accesses for all applicable systems (ie;

Quality systems and / or ERP & integrated tools)

• Quality Documentation Systems (GEODE )
• Responsible for authoring, reviewing and approving department procedures.
• Quality Systems : Change Controls, Deviations / Events, CAPAs, MDOs (PHENIX. / Trackwise)
• Oversee department-owned deviations through closure, as well as provides support on external investigations. Oversees associated corrective and preventative actions (CAPAs.)
• Oversee department-owned change controls and associated action items through timely closure.
• Supports the assessment of site change controls and associated action items with appropriate SMEs.
• Delegate and manage workload with support from the compliance manager and dept. customer service support team
• Represent the department in site audits with internal (Finance, Quality, HSE) and external (FDA, TSA, HHS, FAA, OSHA, Intl Hlth Auth) agencies.
• Supports global Vaccines Industrial Affairs (VIA) requests at site level (GQA / GQD review, inter-company flow, process alignment, etc.)

International Customer Service Leader :

Direct the ICS team in support of the Influenza, Meninge, Acel and T&E product lines to ensure business goals are met in a timely manner.

Ensure working customer service and order management processes and systems are in place to support :

• The commercial export of Fluzone, Menactra, and MenQuadfi, Acel and T&E products as needed
• The non-commercial international export of samples to Heathy Authorities (OMCLs) for registration or lot release testing.
• The non-commercial or commercial export of international clinical samples.
• Align & Interface with Taylor DC Transportation and Logistics Leadership to ensure the Sanofi team and logistics operations is prepared and aligned to deliver SP international business plans.
• Integrate the ICS / Compliance department with the Warehouse & Logistics team to ensure end-to-end management of commercial (Acel EU, Praluent, Menquadfi EU) and non-commercial export shipping requests, and the import of intermediates and raw materials.
• Ensure Sharepoint and all business processes are aligned across the groups to ensure supporting documentation are in place such as :
• Align front end operation to ensure clean order docs are handed to the logistic technicians for further processing.
• Troubleshoot business processes to resolve issues and continually improve the process
• Freight forwarder / courier / broker requirements are aligned
• Permits, financial set up, Required forms.
• Ensure financial flows and customer account information are accurate in SAP
• Manage end to end flows thru Lot release to maintain customer service requirements
• Coordinate with SCBPs and affiliates for direct to customer international orders

Direct a team of ICS and Compliance managers :

• Lead and develop the team
• Direct workload and results
• Report and manage critical department metrics ( QDCI) to drive continuous improvement
• Develop / Evolve the department to support the projected international growth
• Interface with the Toronto and VSC Customer service teams to share best practices and align on I-Shift and other order management processes / tool, where possible

Other duties as assigned .

Context of the job / major challenges

The position will stand up a new group within the Materials Management dept at the SWR site that will handle all international commercial and non commercial order management processes for all products produced at the SWR site for Flu, Meninge, Acel and T&E franchises.

They will be the main interface to the affiliates and supply chain business partners for the SWR international business.

The position will work with the supply chain product leaders and managers to develop and implement business processes and systems to ensure customer orders are processed and shipped for timely delivery and reconciled against planned forecast volumes.

The international business will be the growth platform for the SWR site in 3 yr S&OP thru LRP / LTIP horizon (5-10 yr).

This position will also manage all compliance topics for the material management department. This will require a strong working knowledge of Site and Global Quality Systems tools, with an additional understanding of core operations within the department.

This position is expected to build and maintain working relationships with internal and external customers at all levels in the Sanofi organizations.

This position will have key interfaces with the local RA, Quality, Logistics, Global Supply Chain, Customer service groups in Toronto and France and the international BUs.

This position will require the ability to interface with multiple level in the organization and will require excellent written, verbal communication and presentation skills.

Dimensions / Scope

The international business will be the primary growth sector for the Meninge franchise over the next 5-10 years as we license Menquadfi in numerous international markets.

Planned growth will more than triple sales from $250 mm in 2022 to $750 mm in 2030. The Flu franchise will also grow significantly as we expect International Flu (Fluzone HD / Efluelda sales) to increase from $ 900 mm to $ 1.

6B over the next 3 years. This represents 44% of the Flu growth strategy to achieve over $ 3.5 B in sales goals.

This position will lead a team that will interface with this new customer base, process, and manage the orders and delivery to support this growth strategy.

Requirements

Education / experience

• BS degree with minimum of 5 yrs. relevant professional experience in Customer service environment with international logistics experience and proficiency in GMP Quality Systems (Change Controls, CAPAs, Deviations / Events, Document Lifecycle, etc.)
• Solid working knowledge of SAP required.
• Excellent communication skills with all levels in the company.
• Excellent computer skills with Microsoft Office software, including Outlook, Excel, Word, etc.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity