Continuous Improvement & Performance Manager

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* Job title:

** Continuous Improvement & Performance Manager

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* Location:

** Cambridge, MA

** About the job*
* As  
** Continuous Improvement & Performance (CIP) Manager
** within the  
** R&D team** , you will support the GRA business to continuously improve its ways of working using data and digital technology to be a highly performing and compliant business. You will be responsible for building strong and effective relationships with key business partners to understand their needs, catalyze an agile mindset, and champion the use of digital tools.

In this role, you will serve as the Quality Document Manager (or Quality Document Expert) for GRA - the primary authority on Quality Documentation (QD) lifecycle management within the Quali

PSO Content Management System (CMS). You will partner with Business Process Owners, Subject Matter Experts, and Global Quality networks to ensure GRA's documentation ecosystem is compliant, current, and continuously improving. Your work directly supports global regulatory compliance, patient safety, and the integrity of Sanofi's Quality Management System.

Join the engine of Sanofi's mission - where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions.

** 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.

** Main Responsibilities*
* Establish and Maintain the GRA Quality Documentation Management System:

+ Lead the end-to-end management of GRA's Quality Documentation system within Quali

PSO (CMS), ensuring full compliance with Global Quality (GQ) standards and Medical Clinical Country Quality (MCCQ)
-specific requirements

+ Define, implement, and maintain the GRA QD System in alignment with GQ standards, MCCQ requirements, and applicable regulatory frameworks including 21 CFR Part 211 and GxP regulations

+ Manage the complete document lifecycle - including creation, revision, approval, distribution, periodic review, and obsolescence - in accordance with Quali

PSO procedures

+ Oversee Document Change Request (DCR) management, ensuring changes driven by regulatory updates, process transformations, audit findings, or content improvements are processed accurately and on time

+ Execute and manage periodic review workflows, coordinating SME assessments and delivering verdicts (Keep Effective, Needs Revision, or Make Obsolete) in compliance with Quali

PSO requirements

+ Administer workflow management and electronic signature procedures within Quali

PSO CMS, ensuring proper routing, review, and approval by authorized personnel

+ Maintain and manage the annual Document Plan for GRA, covering new documents, upcoming periodic reviews, planned revisions, and documents scheduled for obsolescence

+ Provide expert guidance to ensure key regulatory activities and processes are documented and implemented in compliance with GxP regulations

+ Support and advise the Business Process Owner (BPO) network throughout the complete QD lifecycle, acting as a trusted subject matter expert

+ Ensure consistency across GRA, MCCQ, and GQ quality documents, adhering to the MOSAIC philosophy by eliminating redundancy and duplication

+ Communicate timely updates on new, revised, and obsolete QDs to internal and external GRA stakeholders

+ Manage GRA user access rights and permissions within Quali

PSO CMS

Lead the QD Training Strategy for the GRA Population:

+ Design and drive a robust, fit-for-purpose training strategy that ensures GRA personnel are qualified and current on all applicable quality documents

+ Collaborate with BPOs, SMEs, and Excellence networks to define, maintain, and simplify Training Curricula content aligned with QD applicability

+ Partner with the GRA QD training team/Hub to implement the defined training strategy effectively and consistently

+ Document and maintain training requirements rationale with supporting evidence, ensuring traceability and audit-readiness

Drive Compliance and Continuous Improvement Across GRA Quality:

+ Apply a scientific, methodical, and documented approach to quality improvement, using data and risk management principles to elevate GRA's compliance posture

+ Contribute to the resolution of audit findings and deviation CAPAs related to QDs, defining remediation actions and tracking their effectiveness

+ Identify, collect, and communicate opportunities for continuous improvement in QD processes, ensuring a follow-up plan is associated with each initiative

+ Support the annual Quality review process, providing QD-related metrics, trend analysis, and risk assessments

+ Apply quality risk management approaches to proactively identify documentation gaps and vulnerabilities before they…