Continuous Improvement & Performance Manager

Job title:

Continuous Improvement & Performance Manager 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 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. 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 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 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 impact compliance Foster a culture of continuous improvement within GRA, encouraging teams to challenge the status quo and adopt best practices

Represent GRA Through Cross-Functional Collaboration:

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 About you You are a detail-oriented, collaborative, and forward-thinking quality professional who combines deep technical expertise in document management with a passion for continuous improvement. You thrive in complex, matrixed environments and are energized by the opportunity to make a meaningful impact on global regulatory compliance and patient safety.

Leadership & Interpersonal Skills:

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 Communication & Analytical Skills 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 Technical & Quality Competencies 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

Minimum Requirements Education:

BS/BA degree in a relevant scientific discipline required

Experience:

5+ years of relevant experience, with at least 2+ years working in Regulatory Affairs (regionally or globally)

Quality Systems:

2+ years of experience in GxP Quality system management, with demonstrated hands-on experience managing Quality Documents through their full lifecycle

CMS Expertise:

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)

Regulatory Knowledge:

Working knowledge of 21 CFR Part 211 and applicable GxP regulatory standards governing documentation and records management

Continuous Improvement:

Demonstrated experience applying quality risk management approaches and continuous improvement methodologies in a regulated environment Why choose us Bring the miracles of science to life alongside a supportive, futurefocused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs. Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science. Help improve the lives of millions of people globally by making drugdevelopment quicker and more effective. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #vhd Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $113.250,00 - $163.583,33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK. Global Terms & Conditions and Data Privacy Statement Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube