Supervisor, QA Sc Emea

**This is where you save and sustain lives**

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

**RESPONSIBLE FOR**:

- Quality oversight on transport and distribution of drugs and medical devices - provide guidance to the countries and ensure compliance with GDP and MDD/MDR for International
- Provide QA expertise, guidance and ensure leverage and harmonization at entity and sub-entity levels on transversal processes related to W&D - integrations, acquisition /merger/demerger etc.
- Support QA aspects related to critical EMEA improvement projects / initiatives
- Supervise QA SC EMEA team
- Provide Quality leadership (processes / requirements / applicable regulations) to ERP/WMS implementations and changes
- Manage replenishment complaint, code activation, and on-status process within EMEA
- QA SME on external and outsourced related activities
- Partner with key stakeholders in the different countries and regions to achieve standardization and assure best practice sharing

**ESSENTIAL DUTIES AND RESPONSIBILITIES**:

- Quality oversight on transport and distribution of drugs and medical devices - provide guidance to the countries and ensure compliance with GDP and MDD/MDR for International:

- Provide expertise on the QA processes linked to transport and distribution and ensure compliance with applicable regulations (GDP/GMP) to Manufacturing and W&D
- Assure representation of the Quality organization for the review of critical processes related to transport and distribution implementations and changes
- Provide quality assessment for lane changes and the need for qualification
- Develop lane qualification approach
- Provide quality guidance on temperature requirements for storage and transportation
- Provide quality guidance in temperature monitoring and the treatment of temperature excursions - assure the presence of necessary tools for assessment and documentation.
- Assure harmonization of processes and documentation for environment control within storage and distribution processes
- Be the contact with Global Supply Chain QA and Represents EMEA region to Global Compliance for the W&D QA processes
- Be the QA reference for International shipments from EMEA
- Provide QA expertise, guidance and ensure leverage and harmonization at entity and sub-entity levels on transversal processes related to W&D - integrations, acquisition /merger/demerger etc.
- Identify quality needs, risks, interdependencies and drive for remediation
- Define quality strategy
- Set up meetings with key stakeholders where needed to determine related tasks and interdependencies and act as project coordinator for the quality part
- Set up planning for quality tasks and coordinate execution
- Help set up the project related quality system elements and procedures to assure correct handling in routine after handover of the projects
- Support QA aspects related to critical EMEA improvement projects / initiatives
- Supervise QA SC EMEA team:

- Manage the Team
- Assign and follow up on the tasks of the team
- Development and retention of people
- Provide Quality leadership (processes / requirements / applicable regulations) to ERP/WMS implementations and changes:

- Provide expertise on the QA processes linked to ERP/WMS and ensure compliance with applicable regulations (GDP/GMP)
- Ensure correct level of partnership and requirements fulfillment with stakeholders (e.g. SC and IT)
- Assure representation of the Quality organization for the review of critical processes related to ERP/WMS implementations and changes
- Assure QA critical roles access and review for ERP systems (JDE and GME)
- Manage replenishment complaint, code activation, and on-status process within EMEA
- QA SME on external and outsourced related activities
- SME for transport and external storage supplier quality
- Provide guidance to the countries for managing external W&D service suppliers
- Ensure process, tools and procedures are in place for approval of transporters and external storage suppliers in compliance with Corporate, European and Local requirements
- Support SQA as lead auditor in 3rd party audits
- Partner with key stakeholders in the different countries and regions to achieve standardization and assure best practice sharing
- Provide support to Quality Management System:

- Ensure the implementation of a central QMS f