Your task and Responsabilities:

• Assure and monitor the supplier and Bayer products quality and compliance vs current regulations in force and Bayer standards to assure the supply of finished goods and services.
• Ensure Supplier and Product Monitoring& Management from QA point of view by establishing and maintaining Performance Dialogues with suppliers including supplier evaluation and CMO / product / processes risk assessments.
• Act as Quality representative in front of main EM stakeholders (Procurement, Operations, Technical, Supply) within the Leadership Teams, when existing.
• Review and evaluation, approval of Deviations & Out of Specifications including root cause analysis.
• Accountable for determination and implementation of CAPA and effectiveness checks ensuring continuous improvement of Bayer product and process.
• Evaluate, from a Quality standpoint, change controls at CMOs related to existing portfolio, Transfers and Projects o Monitoring and Evaluation of PQRs.
• On time communication to Country Quality functions.
• Negotiate and regular update of Quality Agreements established with CMOs o Review and approve analytical validation protocols and reports, generated by third parties Support manufacturing / packaging process of existing and /or transferred/ new products manufactured at CMOs.
• Review process validation protocols and reports in collaboration with Bayer Technical Management functions, ensuring Continuous Process Verification and Statistical Process controls run according to relevant Bayer and Health Authorities guidelines and that are properly reported by CMOs to Bayer.
• Ensure within area of expertise, proper follow up and timely completion of transfer activities at CMOs.
• Where applicable liaise with Innovation & Development for activities under responsibilities in New Product Developments (NPDs).
• Assess and approve quotations related to Projects and NPD quality activities.
• Review and approve Stability protocols and reports. Align on Stability strategies applied at CMOs to demonstrate Product Quality along shelf life.
• Accountable to establish and maintain a Quality Risk Management culture at CMOs. Review and approval of related Risk Assessments and control strategies.
• Where applicable, contribute to the selection, qualification and phase-out of CMOs according to Bayer standards.
• Contribute during regular internal preparations for planned audits at CMO.
• To ensure that Audit & Inspections CAPA are properly and timely implemented.
• Contribution to PQSC and Critical Issues investigations / CAPA implementation and review of CMO Complaint trending review together with Complaint Managers.
• Regular training of suppliers in Bayer related requirements.
• Collaborate with CH Q EM Global function on strategy definition to ensure deployment execution within CH Quality EM.
• Accountable and responsible for timely accomplishment of assigned strategic initiatives and projects o Where applicable, liaise and assure coordination of actions with affiliate entities according to the business requirements.

Who you are:

• Minimum BS in life science, Pharmacy or Engineering.
• Minimum 3-5 years of experience in QA, QC and/or Manufacturing in pharmaceutical /life science industry.
• Experience in quality management as well as sound knowledge of local