Convergence Leader Dupixent Franchise Offer Acceptance H/F

Sanofi Winthrop Industrie

About the job
The mission:

o The Sanofi/Regeneron Alliance is a critically important collaboration to Sanofi. The two companies have jointly developed and commercialized several products with combined revenue forecasts > 10 billion Euros annually and expected to double in five years to >20 billion euros. This role is high impact, high visibility collaborating with global leaders internal and external.
o The Convergence Leader, Dupixent Franchise ensures efficient implementation of major changes across multiple sites driving the performance and compliance of Dupixent, while maintaining supply through the transition. The candidate will work with our external Partner Regeneron and several sites in the network including, but not limited to, Geel, Bioatrium, Waterford, LeTrait, and Frankfurt BioCampus.
o The Convergence Leader drives the assessment, plan, and transition of CMC lifecycle changes endorsed by the Industrial Product team and the Regeneron Change Control Committee.
The candidate ensures the changes are properly assessed for all markets including the regulatory requirements, implementation timing, and supply transition plan;
Ensures the multi-change, multi-site strategy integrated and designed;
Identifies risks and blocking points
The change status is monitored, and updated; plan refreshed as needed
The approval status is communicated, and sites/functions are ready to implement;
The candidate collaborates with the expert's analysis in regulatory, quality, supply chain, and manufacturing operations as part of the convergence planning team including Regeneron partners.
o Additionally, the Convergence Leader will establish automated processes and tools needed within the M&S Specialty Care organization. The candidate will establish the process with colleagues in Supply chain, IT, quality and regulatory.
o The Convergence Leader, Dupixent will lead the Sanofi internal Dupixent Convergence Committee and co-lead the Regeneron/Sanofi Flavor Management Committee and be a key member of the Joint Change Control Committee to ensure alignment of changes are agreed within the alliance.

The main responsibilities:
o Accountable to drive and the execute of the Convergence Plan Process for the plans in his/her/their perimeter
o Accountable to the prepare and the lead the internal Convergence Plan meetings and the Regeneron joint meetings
o Closely collaborates with the IFL and IPLs for the validation of the scenarios proposed, in order to ensure alignment with the industrial strategy, and to identify potential evolutions needed.
Establishes, updates and communicates Convergence Strategy and operational roadmaps for each contributive function (MSat, Manufacturing, GRA etc.)
Prepares the elements for risk escalation when needed
Represents the Convergence Plan and ensures presentation of blocking topics for decision making
Prepares synthetic communications on Convergence Plan for functions or management (view by country, product, site etc.)

o Ensures a link between Regulatory Affairs, Quality and other M&S function, as well as the processes / committees linked to the management of change controls. Provides a global and end-to-end vision of the product lifecycle portfolio enabling thoughtful decision making.
o Leads the continuous improvement of the Convergence Plan process internally and external (Regeneron)

About you
Education/Experience:
o Bachelors/Masters degree in a scientific or engineering discipline
o In depth knowledge of at least two: (Bio-) Process Technology, Manufacturing, Quality/Analytics, Regulatory requirements, supply chain, Project Management, and application thereof in commercial Biopharmaceutical Operations with minimum 10 years of total industry experience.
o Extensive leadership experience (minimum 5 years) in biopharmaceutical industry within the field of bioprocess development or manu