US SpeCare Compliance Head

US Spe Care Compliance Head page is loaded## US Spe Care Compliance Headlocations:
Framingham, MAtime type:
Full time posted on:
Posted Todaytime left to apply:
End Date:
April 20, 2026 (30+ days left to apply) job requisition :
R2842793
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* Job title:

** US Spe Care Compliance Head
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* Location:

** Framingham, MA
** About the Job
** Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and  Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

Provide oversight of cGMP Compliance within the M&S Spe Care GBU. Lead cGMP Compliance projects within the M&S Spe Care GBU Quality Operations through transversal activities across the network of sites. Support sites inspection readiness and assess implementation of Sanofi’s Quality Management Systems at site level in accordance with the company and applicable regulatory requirements.

Coordinate the M&S Spe Care QO governance and manage the reporting activities of key quality indicators (KPIs) across the sites to monitor performance and continuous improvement.  Liaise and network with counterparts in other GBUs, Sanofi Quality Business Process Owners (BPOs) for key transversal compliance topics to achieve synergies and consistencies for implementation of compliance approaches and quality systems.
** Latitude of Action:
** This position reports solid line to the M&S Spe Care GBU Quality Operations Head.  The role holder is required to work autonomously taking decisions in line with Sanofi Global Quality Policy, Standards, Procedures and Processes. The role holder is highly independent strategic thinker and has strong compliance mindset; results-driven, can-do-attitude, solution-oriented, change-agent, patient centric mindset, innovative and resourceful.
** Role Impact:
** The role provides a key link between the Site Quality Units, the related M&S Spe Care GBU Quality Unit and Global Operational Quality Units. It is a key role in ensuring coherent development and roll-out of the Sanofi Quality Management System in line with regulatory requirements, Pharmaceutical Quality System ICH Q10 and Sanofi quality policy across the managed manufacturing sites’ network.
** About Sanofi:
** We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
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* Main Responsibilities:

*** Lead cGMP compliance projects in line with the M&S Spe Care GBU Quality Operations strategy and priorities
* Support sites’ inspection readiness through on-site quality system assessment, gap identification and support for mitigation action plan development
* Support external inspection readiness providing the assistance and guidance in inspection preparation, training on inspection management process, coaching during inspections and inspection response management and follow-up on the corrective and preventive actions.
* Support the Cluster Quality heads in reviewing the effectiveness of the sites’ Quality Systems and Quality Program during site visits, and interactions with the sites on Quality and GMP Compliance matters or appropriate alternative contacts (example: tele-conference or web meeting), with systematic provision of either visit reports or meeting minutes to record items agreed and actions planned.
* Contribute to the Global Quality Dashboard, when necessary, ensuring accurate data reporting to M&S Spe Care GBU Operations Management and Global Quality.
* Coordinate the IRISC activities for the M&S Spe Care GBU.
* Provide leadership with respect of quality culture, quality mindset and quality cGMP compliance performance and continuous improvement engaging all functions and organizational levels across the M&S Spe Care GBU.
* Support Cluster Quality Heads to ensure that the sites' Quality units are adequately trained in Sanofi Global Quality System and Regulatory requirements and providing/organizing as appropriate training…