EM&S External Site Team Head for Large Molecules GenMed

Job Title: EM&S External Site Team Head for Large Molecules GenMed

Location: Morristown, NJ

About the job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

External Manufacturing and Supply (EM&S) Large Molecules GenMed organization is accountable for all Contract Manufacturing Organizations (CMOs) across the GenMed GBU that delivers Sanofi products (for Large Molecules exclusively, Small Molecules are not in the scope). We serve the GBU within M&S with drug substance, drug products, and finished goods, aiming to develop ourselves into a best-in-class organization that continuously strives towards three priorities – (i) Ensure Supply, (ii) Deliver Financially, and (iii) Grow Talent. In addition to Running the Business, we are committed to Transforming the Business by defining our strategic global footprint for preferred partners and deploying the right technology in centralized performance management of CMOs.

Position Overview

The Head of Large Molecules GenMed External Site Team will work   in partnership and alignment within the Global Business Units (GBU) with the cluster/site heads, & all the above site functions such as MSAT, GSC, Strategy/Launch & Sourcing, GDPU, Global Functions (Procurement, Finance, Legal), pool of Transformation Leaders & Program Managers.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Ensures on time & in full delivery of products for CMOs within external site management unit; accountable for reporting of GenMed Large Molecules & EM&S Key Performance Indicators.  Drives continuous improvement in performance of internal and supplier Safety, Quality, Cost, Delivery & Involvement.

• Build and facilitate collaborative business relationships with external partners/suppliers (CMO, CLO, Material Suppliers) & internal business partners (Global Supply Chain, Procurement, MSAT, Legal etc).

• 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.

• Accountable to meet financial targets & ambitions (cost savings); develop and understand the functional P&L.  Create and use digital tools to track progress to financial commitments.

• 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.

• Accountable for the successful financial performance of the team according to budget, including Head Count, activity, Cost of Goods (COGS) and Operational Expenses.  Accountable for negotiation on financial liability for failed or rejected lots to minimize or eliminate Sanofi liability. 

• Accountable for creation, review and approval of Strategic Plans governing the perimeter of the External Site Team.

• Accountable for implementing Life Cycle management projects.

• 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.

• Builds and facilitates collaborative business relationships across all functions internally, both within the Global Business Unit and other departments (Legal, Quality, Finance, Regulatory, Business Development etc).  Is the primary point of contact for business unit; routinely attends appropriate governance forum meetings.  Ensures inventory reconciliation processes are executed according to governing procedures.

• 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 gov