Program Leader - all genders - - #2188368

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About the job

Our Team:

The strategic vision of Sanofi’s Global Medical Device organization is to lead the industry in device-mediated therapies, with the ambition to develop, launch and maintain best-in-class drug-delivery systems and connected medical devices that address patient unmet needs and improve health outcomes. Our specific mission is to support R&D and the Sanofi Commercial Business Units by delivering differentiated technology solutions that enhance the value of our drugs and vaccines, and help patients (and health care providers) facilitate administration, thereby improving their quality of life and empowering them to take control of their disease. Our products and solutions sit on top of our market leading technology platforms, are user-centric, innovative, environmentally sustainable, , producible in high quantities and are continuously improved to meet evolving needs.

We continue to recruit top talent in the industry to help transform the standard of care in the areas of drug delivery devices and stand-alone medical devices. Our teams have developed and released to market auto-injectors, pens, safety syringes, as well as connected medical device technologies and we are in a mode to continue ramp up the volumes and re-new with industry standard and innovative solution our device manufacturing capacities.

Within Sanofi`s Global Device Unit, the LCM Program leader is in charge to develop and deploy the life cycle strategy

The scope includes Manufacturing at CMO`s which are producing components and sub-assembly and the whole Sanofi DP manufacturing network site for device or Packaging activities.

Main responsibilities:

As LCM Program leader you will play a pivotal role in leading and deploying our Life cycle management strategy for your products for primary packaging, devices, and packaging activities

Your responsibilities could focus on two key areas:

• Driving LCM programs among our Sanofi site network
• Ensuring oversight of the respective product/s, managing product performance and their changes

Project/Program Management:

• Lead LCM multidisciplinary teams composed of GDPU SMEs, M&S sites and global functions (procurement, supply chain, global regulatory …) which will support you in building and deploying your project strategies and to develop, industrialize and launch LCM plans (example of projects : tech transfers, capacity increase, components dual source, performance….)
• Oversee projects through completion of milestones following a regulated, structured process and appropriate governance
• Set a high bar for team to push the boundaries, by balancing risk with rigor to optimize and scale LCM projects based on scope, complexity and risk. Develop key KPIs to drive performance excellence in projects and improvements through management of budget, schedule delivery, and scope
• Stay abreast of the technology and Regulatory landscape and compliance standards applicable to the global target markets of Sanofi’s device portfolio, to ensure seamless projects and product compliance with industry standards and regulations (Product maintenance)
• Actively participate as a member of GBU portfolio Team and related governance bodies, contributing to strategic discussions and decision-making processes
• Oversee projects through completion of milestones following a regulated, structured process and appropriate governance

Collaboration with global functions:

• Develop a strong network and partnership with M&S, External Partners, Quality, Regulatory, Supply chain, Procurement, Commercial, and ensure strong stakeholder ties and management by influencing and ensuring fluid communication regarding project objectives, priorities, progress, and critical issues.

About you

Experience :

• 10 years in Pharmaceutical industries
• 5+ years of medical device industry experience
• Experience in Medical Devices and/ or Drug Device Combination product development, and/or LCM.
• Experience as team leader, project manager or similar role
• Interaction with Heath authorities (EMA / FDA…)

Soft skills :

• Collaborate effectively with peers, stakeholders, and partners across the organization to positively impact business results.
• High communication skills towards all levels of the organization internally and to external stakeholders.

Technical skills :

• Knowledge in project management, transversal and team leadership, problem solving principles.
• Ability to think strategically, creatively and purposefully while managing multiple projects.
• Strong technical judgement. Ability to anticipate risks and challenges and guide team to develop strategic solutions to overcome or prevent obstacles
• Ability to structure and maintain high load of information on product, processes, etc. to connect the dots and make educated decisions.
• Knowledge of ISO 13485, MDR (2017/745 if applicable) and 21 CFR 820 and further ISO standards as a plus.
• Knowledge of Design Controls, Change control (incl. respective tools/systems) as well as device risk management, deviation and CAPA processes

Education :

• BS/MS degree in Engineering or related science discipline. An advanced degree is a plus.

Languages :

• Business fluent (written and oral) in English required, French or German a plus.

Pursue Progress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi