Head of External Manufacturing APAC

Our Mission:

To lead and develop EM APAC DP & API team to ensure achievement of business goals and targets with high level of customer service & quality and in full compliance with Sanofi standards and processes. Support General Medicines GBU to rollout the IA EM&S strategies across all APAC countries.

Main responsibilities:

Guarantee a high level of performance from all CMOs in the perimeter in terms of Quality, Customer Service and Costs. Be responsible of products supply continuity, anticipate potential issues (back-up, inventory, ) and develop & deliver action plan in case of unexpected rupture. Ensure high level of HSE and Quality at CMOs level in line with Sanofi standards and be accountable of CAPAs implementation after audits. Select appropriate CMOs as per Sanofi guidelines and requirements and in a spirit of CMOs network rationalization and simplification. Drive continuous improvement at CMOs level (including through SMS deployment) to target best-in-class performance and adapt to new GMP or Sanofi requirements.

Be the point of contact of APAC & India commercial operations heads in order to ensure full alignment on vision and fulfilment of their business needs. Accountable for creation, review, and approval of Strategic Plans for APAC region in alignment with EM&S approach. Drive all M&A and BD projects for EM&S for APAC region, participate to due diligence and site visits & provide recommendations for Go/No Go decisions. More specifically, lead all China projects (one BD project signed recently, others on-going), develop strategy to manage future CMOs including creation of a team in China at the latest when first CMO will become operational (between 2025 & end 2026).

Accountable of EM&S APAC P&L and to meet financial targets & ambitions (cost savings, headcounts, transfer costs, ) Create and use digital tools to track progress to financial commitments. Accountable for negotiation on financial liability for failed or rejected lots to minimize or eliminate Sanofi liability. Accountable for ensuring that project and sourcing activities are appropriately resourced or prioritized.

Accountable for the adherence to the Risk Management Program to identify, evaluate, document, and communicate risks potentially impacting quality and compliance; involves a multi-disciplinary team to define remediation plans to mitigate risks impacting products and GxP operations. Ensure Compliance through active participation at all applicable quality governance forums (including Quality Management Reviews and Periodic Business Reviews). Accountable for approval of critical deviations. Accountable for on time Quality System related records, also reviews and approve all Category 3 Change Requests Ensures organizational compliance to CMO Management processes ensuring Core Team, Internal Steering Committee (ISC) and JSC meetings are routinely held, decisions and actions are documented, and the correct attendees participate.

Accountable to understand the contract guidelines and the impact to the product/departmental P&L. Accountable to understand the products/ CMOs from an operational & financial perspective and responsible for routine technical support Build and facilitate collaborative business relationships with external partners/suppliers (CMO, CLO, Material Suppliers) & internal business partners (Global Supply Chain, Procurement, MSAT, Legal etc). Accountable for implementing Life Cycle management projects Accountable for standardization of processes and procedures required to manage CMOs and related work within External Site Team.

Serve as the first level of escalation from the External Manufacturing Product Teams as it relates to problems encountered with CMO activities, actively participates in CMO driven Joint Steering Committee (JSC) meetings. Escalates issues to appropriate forums, as needed Interface with external regulatory authorities as required

3. Participate actively to negotiations with procurement team

Accountable for ensuring the appropriate organizational design, resources, skill sets and processes to effectively deliver on all EM&S APAC commitments. Alternatively ensure proper prioritization of activities to fit within the organizational design Constant dialogues with teams so as to engage motivate and lead them for more empowerment & responsibilities. Develop culture of strategic planning, individual development plan & succession plan to ensure full fit with future business needs and develop people accordingly

Scope : Large team of 16 + members including 3 direct reports, Around 25 CMOs, 60M spends

About you

Technical skills

Leadership skills

Inspires trust through empathy and authenticity. Empowers and recognizes others to create powerful relationships and networks.