Simple to Operate Lead

About the job

Join our dynamic team as Simple to Operate lead for Non-GxP Documentation Management responsible for defining, implementing, and optimizing processes related to the creation, management, control, and storage of Non GxP process documentation and principles.

This role drives standardization, quality assurance, and continuous improvement in documentation management practices, ensuring alignment with company strategy and regulatory requirements. This position is pivotal in maintaining the highest standards of document management to foster operational efficiency and adherence, contributing significantly to our company's success and global impact.

This role also ensures that Global Process Owners (GPOs), Global Process Leads (GPLs), Local Process Champions (LPCs) comply with the framework set up by “Simple to Operate” and its evolution over time in line with the Sanofi strategy.

Scope

All Sanofi Principles

All non-GXP documentation such as Global Operating Procedure (GOP) Standard Operation Procedures (SOP), Working Instructions (WI) 

Core Model Development

• Establish and own comprehensive Core Model for non-GxP Documentation Management

• Define end-to-end processes for creating, managing, reviewing, and storing documentation

• Develop standardized documentation framework

• Coordinate with GxP documentation owners and Quality teams

Strategy and Implementation

• Ensure compliance with standardized documentation framework (Authorized Documents, Hierarchy, Relationship Rules, Workflows)

• Monitor framework adherence and report to senior leadership

• Establish Qualipso as single source of truth for process documentation

• Collaborate with Non-GxP Documentation Centre of Expertise

Quality Assurance

• Define and implement documentation quality KPIs and reporting mechanisms

• Partner with analytics teams to establish performance management solutions

• Monitor and report on performance and compliance metrics

Tools and Templates

• Identify and implement standard tools (QualiPSO, ServiceNow)

• Define and implement standardized templates

• Participate in tool governance and maintain partnerships with digital stakeholders

Innovation and Technology

• Identify opportunities to leverage emerging technologies (GenAI, translation tools, automation) across Documentation Management lifecycle

Stakeholder Communication

• Engage with leadership to align framework with strategic goals

• Communicate regularly with Global Process Owners, Communities, and Governance bodies

• Facilitate executive-level governance meetings and workshops to drive adoption

Experience and skills

We are seeking a dedicated and experienced professional with a background in process management and/or quality management, document management.

The ideal candidate will have

• Expertise in managing documentation systems, knowledge data bases (not technical management) and appetite to detail in maintaining document accuracy and adherence

• Expertise in process design and implementation and change management

• Ability to manage complex workflows and ensure timely completion of document reviews and change requests

• Excellent communication skills, capable of delivering training, addressing inquiries, and interacting with various stakeholders

• Approach to identifying risks, proposing improvements, and enhancing team effectiveness

• Leadership skills

• Problem-solving skills, with a data-driven approach to identifying opportunities for improvement and optimizing operational efficiency

• Experience building reports in Excel, PowerPoint, Power BI as a big plus

Education:

• Master's degree in Finance, Economics, or Business Administration or similar

Languages:

• Fluency in English

• Bring the miracles of science to life alongside a supportive, future-focused 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

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