Continuous Improvement & Performance Manager

Sanofi•Cambridge, MA

1d•$113,250 - $163,583•Onsite

About The Position

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 QualiPSO 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.

Requirements

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
Demonstrated ability to use appropriate interpersonal styles and techniques to build internal networks and lead negotiations with internal and external stakeholders in a highly matrixed structure
Ability to act as a change agent during times of transition and transformation, guiding teams through evolving quality requirements and digital tool adoption
Ability to operate with discretion and confidentiality about sensitive data
Excellent oral and written communication skills — invaluable in communicating with global, cross-functional, cross-cultural, and multi-disciplinary teams
Experienced in communicating vertically and horizontally within an organization with necessary cultural awareness and sensitivity
Strong analytical skills with the ability to analyze complex information, identify trends, and make data-driven decisions to improve documentation processes and quality outcomes
Ability to rapidly understand and analyze complex problems/situations and actively lead and/or participate in the management of solution development and implementation
Proficiency in electronic document management systems, particularly Veeva CMS, including document creator and document controller role functions
Strong project management skills for managing documentation projects, including timelines, resources, and deliverables
Solid knowledge of GxP compliance requirements and their application to quality documentation
Familiarity with document lifecycle management best practices, including DCR management, periodic review workflows, and electronic signature procedures
Involved in implementing and optimizing business strategies globally, thinking creatively and outside the box, while ensuring transparency and clear decision-making

Responsibilities

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 (Keep Effective, Needs Revision, or Make Obsolete) 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
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 QualiPSO CMS
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
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 impact compliance
Foster a culture of continuous improvement within GRA, encouraging teams to challenge the status quo and adopt best practices
Serve as GRA's voice and advocate in global quality networks, ensuring GRA's needs are understood and addressed at all levels
Serve as an active member of MCCQ (QD & Training networks) and Global Quality (Training CoPs, Doc Cluster) committees and projects
Coordinate transversal QD reviews across MCCQ and GQ, facilitating alignment and consistency
Facilitate and coordinate GRA SME requests for MCCQ processes, acting as the primary liaison
Leverage cross-functional collaboration opportunities to drive innovation in documentation practices and share best practices across the broader Sanofi quality community