Continuous Improvement Manager

Sanofi

Continuous Improvement & Performance Manager leading the GRA Quality Documentation system at Sanofi. Ensuring compliance and continuous improvement in quality processes and documentation.

Posted 5/16/2026full-timeCambridge • Massachusetts, New Jersey • 🇺🇸 United StatesMid-LevelSenior💰 $113,250 - $163,583 per yearWebsite

About the role

Key responsibilities & impact

Lead the end-to-end management of GRA's Quality Documentation system within QualiPSO (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 QualiPSO 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 in compliance with QualiPSO requirements
Administer workflow management and electronic signature procedures within QualiPSO 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
Communicate timely updates on new, revised, and obsolete QDs to internal and external GRA stakeholders.

Requirements

What you’ll need

BS/BA degree in a relevant scientific discipline required
5+ years of relevant experience, with at least 2+ years working in Regulatory Affairs (regionally or globally)
2+ years of experience in GxP Quality system management, with demonstrated hands-on experience managing Quality Documents through their full lifecycle
Advanced proficiency in Content Management Systems (CMS), with direct experience in both document controller and document creator roles within an electronic document management system (preferably Veeva)
Working knowledge of 21 CFR Part 211 and applicable GxP regulatory standards governing documentation and records management
Demonstrated experience applying quality risk management approaches and continuous improvement methodologies in a regulated environment
Excellent time-management and operational skills including planning, organizing, and the ability to motivate and influence others without direct authority
Strong sensitivity for a multicultural and multinational environment
Excellent oral and written communication skills — invaluable in communicating with global, cross-functional, cross-cultural, and multi-disciplinary teams
Strong analytical skills with the ability to analyze complex information, identify trends, and make data-driven decisions to improve documentation processes and quality outcomes.

Benefits

Comp & perks

health and wellbeing benefits including high-quality healthcare
prevention and wellness programs
at least 14 weeks’ gender-neutral parental leave

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality Documentation managementGxP Quality system managementDocument lifecycle managementQuality risk managementContinuous improvement methodologiesRegulatory complianceDocument Change Request (DCR) managementContent Management Systems (CMS)Electronic document management systemData analysis

Soft Skills

Time-managementOperational skillsPlanningOrganizingMotivating othersInfluencing without authoritySensitivity to multicultural environmentsOral communicationWritten communicationAnalytical skills