Job Title: External Manufacturing Vx PPM and Operations Lead, Japan

Effective Date: 3/1/2025

Department: External Manufacturing, Japan

Division: EM&S

Reports to: Head External Manufacturing Japan

Location:  Hatsudai, Tokyo.

Briefly summarize the primary purpose or function of the job:

• Coordinate and monitor the execution of contracts with Sanofi external partners and follow-up execution
• Responsible for on time execution of projects
• Provide strategic direction in the management of Products Portfolio
• Ensure compliance with internal and regulatory requirements, managing all aspects of tech transfers and commercialization into new CMOs.

Leadership qualifications summary:

• Proactive Leadership: Take initiative in uncertain situations and promote innovative solutions.
• Customer Focus: Maintain a customer-focused and solution-oriented mindset.
• Assertiveness and Influence: Act decisively and demonstrate influence within the organization.
• Intercultural Cooperation: Work effectively in intercultural environments, fostering teamwork and shared objectives.
• Accountability: Take responsibility for actions and empower teams to communicate and work beyond siloes.
• Continuous Improvement: Continuously seek best practices and areas for improvement.

Formal Education and experience Required:

Basic qualifications are the minimum requirements that an individual needs to meet the needs to meet the job description. The requirements need to be quantifiable (e.g., two years of project management experience).

• Scientific training (pharmacist, scientist, engineer...)
• Certified in Planning and Inventory Management (CPIM) is a plus
• At least 5 years in the pharmaceutical / biologics industry; experience with Vaccines
• At least 3 years’ experience in manufacturing of DP/DS or manufacturing support departments (e.g., MSAT, Quality)
• Communication Skills: strong ability to engage, motivate, work in matrix organizations, in a multicultural environment
• Organizational Understanding: good grasp of organizational structures and quality processes
• Flexibility and Urgency: ability to manage projects with a sense of ownership, urgency and adaptability
• Experience in cGMP Environment: contract management and continuous improvement principles
• Language Skills: fluency in Japanese and English.

IV – PRINCIPAL DUTIES AND RESPONSIBILITIES

• Manage relationship with partners and monitor the execution of contracts:
  • Manage the implementation of new flows and optimize them
  • Co-write the new specifications (PTS) in project mode under the leadership of Tech transfer team and manage the changes for the specifications in routine mode.
  • Ensure that the CMOs carry out the productions according to the Specifications and contracts in place.
  • Ensure that production capacity is aligned to requirements and contract obligations.

• Manage the production/release flow of subcontractors to meet customer commitments (deadlines/quantities/quality)
  • Follow plan made by global Supply Chain for Vaccines
  • Guarantee proper execution of production plans between External Partners and Sanofi on Partners sites within a short-term horizon of 0-6 months, for on-time, in-full delivery of product from partner to customers.
  • Follow production indicators
  • Coordinate deviations and Change controls in collaboration with EM&S Teams, Sanofi site/entity QP and Quality team of the affiliate

• Coordinate all industrial flows between Partners and Sanofi sites:
  • Lead the execution follow-up in accordance with the planned commitments for all areas supporting external partners (QA, QC, Supply, Logistics, Operations, MSAT, affiliates…) ensuring cross functional representation and participation.
  • Manage purchase orders from procure to payment for Vaccines CMOs in ERP
  • Escalate key risks and issues to senior management, EMPT and risk manager

• Monitor partner performance (KPIs) against production goals, identify and resolve gaps, and ensure standard governance model is implemented to track performance.

• Post release actions
  • Participate in quality audits and inspections in collaboration with EM&S Quality preparation and closure meeting)
  • Participate in investigations related to customer complaints/CAPA and audits.

• Projects with External Partners:
  • Contribute to Binding Offers and project definition as needed
  • Manage tech transfer projects as project manager/leader or contribute to the project as project team member
  • Support and manage project initiatives, including new product introductions and continuous improvement projects.

• Optimization Projects:
  • Evaluate current processes and product portfolio to identify opportunities to optimize and streamline CMO portfolio or identify back up strategies to reduce risks.

• Promote HSE:
  • Cultivate a culture that prioritizes Health, Safety, and Environment (HSE) activities within the team.

V – ADDITIONAL RESPONSIBILITIES AND MAIN PROFESSIONAL RELATIONSHIPS

Additional Responsibilities

• Ensure reporting to internal and external clients through follow-up meetings
• Key member of the Industrial Product Teams
• Key member part of the periodic Business Reviews
• Contribute to lessons learned of projects / topics.

The candidate is the primary Sanofi interface for all communications with External site manufacturing activities (virtual plant manager) and is expected to manage operations and communicate effectively to create value in meeting Sanofi’s business objectives.

The position supports all project management initiatives at the supplier site including tracking KPIs, manufacturing technical transfers, new product introductions, compliance initiatives and continuous improvement projects. The candidate will routinely manage and contribute to projects requiring close collaboration with EM Teams, Technical Development, Regulatory Affairs, Legal, Quality, Finance, Logistics, Planning and Business Operations.