Global Artwork Business Process Owner

Job Title: Global Artwork Business Process Owner

Location: Morristown, NJ

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

The Global Development & Packaging Unit (GDPU) Artwork & ePI team is at the forefront of Sanofi’s transformation journey, enabling seamless, compliant, and patient-centric packaging and labeling operations across the product lifecycle.

Our mission is to simplify and standardize artwork and electronic product information (ePI) processes globally, ensuring the right information reaches the right patients-at the right time, in the right format. We serve as strategic enablers of regulatory excellence, operational agility, and digital innovation across Sanofi’s product portfolio. We are building harmonized systems, fostering cross-functional collaboration, and driving automation through technologies like smart packaging, QR codes, and centralized digital repositories.

Our team bridges R&D, Manufacturing & Supply, Digital, and Commercial functions-creating a cohesive ecosystem that reduces time-to-market, enhances compliance, and supports sustainability through paper reduction and global process harmonization.

As guardians of product information integrity, we’re not just managing artworks-we are shaping the future of patient trust and product transparency.

A centrally managed control tower will oversee the program's execution, ensuring consistent guidance, sharing best practices, and coordinating efforts across all countries and manufacturing sites/CMO. This centralized model will enable Sanofi to maintain agility, ensure regulatory compliance, and drive innovation as we enhance our Artwork solutions worldwide.

The Global Business Process Owner - Artwork plays a pivotal role in Sanofi’s global transformation agenda to transform artwork operations and enhance patient engagement, regulatory compliance, and operational agility. Reporting to the Head of Artwork & ePI, this role is responsible for designing and driving the global Artwork program roadmap, coordinating regulatory alignment across regions, and delivering sustainable, scalable solutions in partnership with cross-functional stakeholders.

This is a high-impact & critical leadership role accountable for defining and implementing the long-term strategic roadmap for Sanofi’s global Artwork transformation, ensuring regulatory excellence, digital innovation, and measurable enterprise-wide value creation. This role directly supports Sanofi’s ambition to lead the global pharmaceutical industry in digital artwork transformation.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

The

Global Artwork Business Process Owner plays a pivotal role in defining, governing, and continuously improving the global end-to-end artwork process across Sanofi. This role is accountable for establishing global standards, driving operational excellence, and enabling digital transformation across systems, people, and workflows.

Strategic Leadership & Governance

• Define and own the global artwork lifecycle strategy across the product lifecycle-from design initiation to commercial execution.
  
• Lead the transformation roadmap, including simplification, harmonization, and integration of global artwork processes.
  
• Establish and maintain global governance frameworks, including SOPs, KPIs, change controls, and audit readiness protocols.
  
• Chair and lead the Global Artwork Community of Practice to ensure knowledge sharing, standard adoption, and continuous capability building.
  
• Align artwork process strategies with broader M&S, Regulatory, Quality, and Digital objectives.
  

Process Ownership & Governance

• Own and oversee the global end-to-end artwork process, ensuring it is standardized, effective, and scalable across all business units, product types, and regions.
  
• Establish, maintain, and continuously improve the governance framework for artwork management, aligned with Sanofi�s regulatory, quality, and operational excellence objectives.
  
• Define and implement artwork workflows, documentation controls, and system (onepack) interactions (e.g., with Regulatory, Supply Chain, and Commercial) to ensure process consistency, quality, and traceability.
  
• Lead the adoption of best practices and simplification efforts, driving harmonized data collection and integration to support faster time-to-market and digital insights.
  
• Set up and lead governance forums in alignment with other Global Process Owners (GPOs), ensuring cross-functional integration, data alignment, and continuous improvement through automation and AI where relevant.
  

Change Management, Training & Knowledge Management

• Lead change management initiatives related to artwork process updates, system enhancements, and global harmonization-ensuring smooth adoption and minimal disruption across sites and functions.
  
• Design and deliver training programs in collaboration with regional and local artwork teams to build capabilities on new tools, standards, and ways of working.
  
• Establish and maintain a central knowledge repository for artwork management-including SOPs, playbooks, best practices, and lessons learned-to ensure global consistency and transparency.
  
• Act as a mentor and subject matter expert for artwork leads and execution teams, providing ongoing guidance, coaching, and process support.
  
• Collaborate with Quality, Regulatory, and Risk functions to identify key process risks, and drive optimization, simplification, or standardization efforts where needed.
  

Digital & Technology Enablement

• Act as the business owner for global artwork systems such as OnePack, VISTAlink, and other AMS platforms.
  
• Collaborate with Digital to ensure system scalability, data governance, and compliance with validation and cybersecurity standards.
  

Regulatory & Quality Compliance

• Ensure global compliance with regulatory frameworks, including HA requirements, CCDS alignment, and GMP standards.
  
• Oversee global artwork change control processes and validation protocols.
  
• Monitor regulatory trends and implement timely updates in coordination with Regulatory Affairs and local markets.
  
• Track and resolve non-compliance issues and maintain robust documentation for audits.
  

Cross-functional Leadership & Team Management

• Collaborate with senior leaders and stakeholders across Regulatory Affairs, Quality Assurance, Manufacturing & Supply, Commercial, and Digital to ensure artwork processes are fully aligned with business strategy, operational priorities, and product lifecycle milestones.
  
• Serve as the primary liaison between global and regional Artwork functions, system owners (e.g., Digital/IT), and enterprise support functions (e.g., Finance, Procurement) to facilitate process alignment, knowledge sharing, and effective integration of new tools and methodologies.
  
• Provide functional direction to site-level artwork teams, including capability building, training programs, and performance coaching.
  
• Act as the central liaison across global and local teams to harmonize execution and reduce variability.
  

Performance Management & Reporting

• Define and monitor KPIs such as cycle time, first-time-right rates, and quality compliance.
  
• Lead regular performance reviews with key stakeholders and senior leadership.
  
• Maintain audit trails, compliance logs, and reporting dashboards to ensure transparency and readiness.
  

About You

Basic Qualifications:

• BS/BA in a Scientific discipline, Regulatory, Manufacturing, Supply Chain or related. Master�s degree is preferred.
  
• Minimum of 8 years of experience in the pharmaceutical or biotechnology industry, with direct exposure to Artwork, Labeling, Regulatory Affairs, or Manufacturing & Supply.
  
• Strong understanding of regulatory compliance requirements (e.g., GMP, CCDS, HA submissions) and global artwork-related standards and best practices.
  
• Proven experience in leading digital transformation initiatives, particularly involving artwork process and systems implementation, lifecycle automation, or process digitization within a regulated industry.
  
• Demonstrated leadership and team management capabilities, with experience steering cross-functional and multicultural teams.
  
• Outstanding communication and stakeholder engagement skills, with the ability to align diverse global functions around strategic goals.
  
• Agile mindset with a strong problem-solving orientation and a history of successful project delivery in complex environments.
  
• Regulatory certifications (e.g., RAC) or equivalent professional credentials are a plus.
  

Soft skills:

• Willing to challenge �conventional†thinking
  
• Not reluctant to make tough/unpopular decisions and to face conflict. Motivated and able to motivate others around him/her
  
• Strong communication and inter-personal skills, especially in a cross-functional context. Ability to maneuver in cross-functional setups and to generate buy-in across different stakeholders is a plus
  
• Robust project management skills (incl. planning) - Able to develop comprehensive workable solutions incorporating the constraints and inputs from all functions in complex situations
  
• Ability to quickly draw the big picture and solve problems: understand quickly the key issues at stake for the different functions and develop workable solutions accordingly.
  

Technical skills:

• Successful, multi-year track-record of managing complex, cross-functional projects /programs
  
• Experience in Artwork, packaging and/or design to Value (DTV) is a plus
  
• Languages: French and/or English. An additional language is a plus
  

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
  
• Discover endless opportunities to gain experience 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 diligent 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.
  

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.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.