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Head of External Manufacturing APAC

AT Sanofi U.S.
Sanofi U.S.

Head of External Manufacturing APAC

Hinganghāt, India

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:

  • Ensure products delivery from CMOs at Sanofi standards
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.

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  • Drive EM&S strategy implementation & lead key strategic projects
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).

  • Secure financial performance
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 of full compliance with Sanofi standards & processes
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.

  • Own contractual & business relationship with CMOs
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.
  • Represent Sanofi & EM&S with external partners
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

  • Ensure People development & PTW behaviours
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
  • Education: Graduate/ post graduate in Pharmacy/Engineering with financial Management knowledge or Bachelor's degree with scientific background or equivalent or master's degree with scientific background or equivalent
  • Experience: Minimum 15 years of experience in the Pharmaceutical Industry & allied industry. People Leadership experience of 5+ years
  • Skills
Technical skills
  • Basic or good understanding of data management and IA digital products
  • Knowledgeable in E2E product & industrial strategy, performance management, project management
  • Knowledgeable in pharmaceutical industry technologies
  • Strong analytical skills.
  • Good command of KPI target setting & monitoring

Leadership skills
  • Strategic thinking: analyzes current and future scenarios, disrupts the status quo with innovation, while remaining pragmatic and focus on priorities. Able to shape a vision. Able to lead & animate networks, teams, experts - Strong communication skills.
  • Results orientation: Demonstrated ability to drive initiatives from concept to execution.
  • High level of autonomy. Executes, comfortable with ambiguity,and adapts with agility. Takes calculated risks and anticipates potential issues.
  • People development: Engages and leverages everyone's strengths while being highly self-aware. Instore the culture of feedback & empower people to grow & manage his/her career path.
  • Relationship & Influence: able to manage ambiguity and partners without solid reporting line.
Inspires trust through empathy and authenticity. Empowers and recognizes others to create powerful relationships and networks.
  • Stretched ambition and act. Encourages the teams to stretch and do things differently & creates space for the teams to act.
  • Commit to Patients and full product quality. Makes sure the teams understand how to act for patients and customers.
  • Approaches the role with humility and thinks Sanofi first.
  • Languages : Fluent English

Client-provided location(s): India
Job ID: Sanofi-https://jobs.sanofi.com/en/job/mumbai/head-of-external-manufacturing-apac/2649/18476780672
Employment Type: Other