About the job
Our Team:
At Sanofi R&D, we develop future medicines that improve patients' lives worldwide. R&D Supply is managed in collaboration by 3 departments: Clinical Supply Chain Operation (CSCO), Chemistry, Manufacturing and Controls (CMC) and Global Quality Operation (GQO). Those 3 departments include key roles who are responsible to manage supply flow to patients globally for clinical testing according to quality requirements. The Supply Support Team Leader leads a team of diverse roles (depending on the location) including Global Supply Study Supports (GSSS), Investigational Product Supports (IPS), CMC Material & Documentation Flow manager and Temperature excursion Quality manager who provides support on supply activities that can be centralized to a worldwide team. Activities must be done ensuring quality, timely delivery, regulatory compliance, and with an accurate tracking through our internal systems.
The Global Supply Support Team Leader serves as the primary liaison to global functional heads on business topics such as metrics, prioritization, and performance and reports to:
- In Hungary:
- Direct reporting line: to the CSO Study Management Head (HU)
- Functional reporting lines to: HUB Coordinator for CSCO, Clinical Supplies Quality Manager for GQO & Head of Demand & Supply for CMC
- In India:
- Direct reporting line: to the Clinical Study Support Head (India)
- Functional reporting line: to Clinical Supply Chain International Management and HUB Coordinator
Main responsibilities:
- Clinical Trial & Supply Knowledge: Understand clinical trial design, protocols, and regulatory requirements (GxP)
- Manage investigational product lifecycle: kit types, shelf life, production planning, depot management, distribution, reconciliation, and returns/destruction
- Apply knowledge of clinical endpoints, randomization, dosing regimens, cohort management, and stratification factors
- Team Leadership & People Management: Lead, coach, and develop team members through clear direction and targeted training
- Conduct performance reviews, set objectives, and support career development and well-being
- Foster Sanofi's culture of open communication, collaboration, and recognition
- Ensure team qualification, expertise development, and effective onboarding
- Operational Management: Optimize workload distribution and resource allocation across the team
- Oversee planning aligned with study timelines and milestones
- Align team objectives with organizational goals and develop action plans
- Stakeholder Collaboration & Communication Build and maintain relationships with key internal and external stakeholders
- Collaborate closely with CSCO, GQO, and CMC to ensure alignment on goals and ways of working
- Provide regular status updates, KPIs, and analysis of cross-project trends and risks
- Ensure timely information flow and escalate critical issues
- Problem Resolution & Continuous Improvement: Proactively identify and resolve issues, risks, and systemic challenges
- Drive process optimization, standardization, and innovation for efficiency gains
- Implement corrective actions for audit findings and operational issues
- Location-Specific Responsibilities depending on roles to oversee: IPS (Investigational Product Services) Provide expertise and support on temperature excursion, import license, study RFP for distribution provider, reconciliation and any other new activities identified as IPS responsibility.
- GSSS (Global Suply Study Support): Provide expertise and support:
- On IMP transfers to depot in IRT, Inventory Product Stock Management (IPSM) tracker, destruction of expired IMP and AxMP throughout the study lifecycle, reconciliation, monitoring IRT interface failures with Sanofi supply tools, accurately capturing supply plans in Sanofi Clinical Supplies tools (ERP)
- Preparing and maintaining mandatory shipment documentation prior shipment preparation, in filing and archiving IMP-related documents, in preparation for regulatory inspections
- In monitoring IMP and AxMP stock levels throughout the study, tracking shipments throughout the study duration,
- In managing service provider purchase orders and invoices, ensuring regular financial tracking and compliance.
- GQO (Global Quality Operations) :
- Acts as a backup of the Temperature Excursion Manager. As such, ensures activity coverage during Temperature Excursion Manager out-of-office periods
- Provides directions on product acceptability for use in cases where temperature is outside the limits of stability statement
- Ensure temperature excursion management complies with Good Practices (GxP) and Sanofi procedures
- Serve as the Key Expert User for TEX (temperature excursion management and recording)
- Material & Documentation Flow Management: Oversee the management of on/off boarding of external resources
- Oversee the management of training environment and systems
- Oversee the management of documentation and the coordination of products (Drug Products and Marketed Products) receipt and transfer to support supplies delivery
About you
- Experience: 7+ years’ experience in the pharmaceutical/CRO industry in clinical operations/ development with at least 2 years of people management or team coordination
- Technical skills: High level of knowledge in clinical operations focus on supply chain flow.
- Experience in Quality field and knowledge in in GxP regulations is a plus.
- GMP certified
- Experience in Project management
- Ability to navigate in several tools: ERP, Documents management, recording tool, Power BI/App, etc
- Familiarity with TEX (temperature excursion management and recording tool) and document management tools: VeevaVault (QualiPSO), Veeva RIM
- Soft Skills: Result oriented
- Ability to work productively with a broad and diverse group of stakeholders
- Autonomy and proactivity; ability to prioritize tasks
- Collaborative leadership
- Excellent oral and written communication skills
- Education: B.Sc. in Life Sciences (or equivalent)
- Languages: Strong English skills (verbal and written), able to exchange fluently in a global environment
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!