ITS Expert Quality – Distribution, Customer Care & EIM
Sanofi
Barcelona, Spain
hace 4 días

JOB MISSION

The ITS Expert Quality - Distribution, Customer Care and EIM is a key role in the ITS Quality and Operations team, accountable to ensure that ITS projects, processes and services are delivered with the right level of quality and compliance with Sanofi and regulatory expectations, supports audits and inspections as well as self-assessment / reviews and contributes to the evolution of the ITS Quality Management System.

This position covers a diverse scope with critical solutions both on-premises and SaaS, PaaS in an international ecosystem with high performance and compliance stakes.

The collaboration with the internal and external stakeholders is key for this position :

Internal Stakeholders are global in different teams (ITS Units, Global quality / Business quality, Internal Control, Internal Audit, Data Privacy office, HR and finance) External Stakeholders are Regulatory Agency Inspectors, External Auditors, Supplier and Service Providers

The Sanofi Barcelona Campus is a global center of expertise with the challenge to accelerate the integration of digital technology into IT applications for our industrial and EIM activities.

RESPONSIBILITIES

Ensure compliance of the development, delivery & maintenance of Business Information Solutions

  • Provide training, guidance and adequate support with respect to applicable regulatory (e.g. GxP, SOX) and internal requirements for the design and implementation of computerized systems, the application of project methodology and validation / qualification process.
  • Define validation / qualification strategy and provide advice, guidance and approval on validation activities in collaboration with Business Quality and project teams following a risk-based approach.
  • Provide guidance and oversight for the management of CAPA related to the supported systems.
  • Support ITS Risk Management through identification, characterization and development of mitigation plans, in collaboration with ITS Units and other stakeholders.
  • Support the ITS Organization during audits and inspections

  • Collaborate with Business System owners, Business Quality and Solution Center representatives to prepare for regulatory inspections and internal audits, respond to questions and address findings through corrective / preventive action plans to improve compliance and effectiveness of the Quality Management System
  • Support internal quality assessments and reviews for assigned projects and applications to ensure compliance and / or application of best practices
  • Contribute to the development of continuous improvement of the ITS Quality System, Computerized System Lifecycle methodology and ITS Processes

    FORMAL EDUCATION and SKILLS REQUIRED

  • Master's degree in Health industry, Quality, computer science or related scientific or technical discipline.
  • 5+ years in Computerized Systems compliance in regulated environments (GxP and SoX) such as Pharmaceutical / biotechnology industry, of which 3 in a global, cross-functional, multi-national environment
  • Experience with Industrial processes / solutions is a differential
  • Working knowledge of information security to collaborate with the security officer.
  • Advanced knowledge of Risk Management, Project & Application management, compliance of computerized systems (e.g. GxP, SOX).
  • Strong Problem solving, decision making, transversal collaboration and communication skills.
  • Intermediate change management skills.
  • LI-EUR

    At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers.

    We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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