Qm External Manufacturing Americas

QM External Manufacturing Americas Your task and responsibilities: Act as delegate of the Responsible Person ("Fachtechnische Verantwortliche Person (FvP)") of BCC AG according to SOP-A. Ensure that relevant BCC procedures are considered for the Quality and Compliance related tasks pertaining to the position. 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, Transfersand Projects, Monitoring and Evaluation of PQRs. On time communication to Country Quality functions; negotiate and regular update of Quality Agreements established with CMOs. 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; where applicable, liaise and assure coordination of actions with affiliate entities according to the business requirements. Skills & Qualifications Minimum BS in life science, Pharmacy or Engineering with minimum 5-7 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 and regional cGMP, Dietary supplements, Cosmetics and all other relevant quality assurance guidelines. Proficiency in English, written and verbal, with ability to communicate to different audiences. Additional local languages are beneficial. Readiness in working within innovation and digitalized environment. Agile learner with ability to anticipate needs and be pro‑active. Cross‑functional team Player with excellent communication and negotiation skills for international interactions. Demonstrate workload prioritization and time management. Strong flexibility to adapt to different business cultures. Experience working with External Manufacturers. Ability to travel up to 20% of time. Strong analytical and problem‑solving skills. Período de aplicación: 21 al 3 de septiembre Código de referencia División: Consumer Health Ubicación: Mexico: Ciudad de México: Ciudad de México Área funcional: Calidad Grado de posición: VS 1.2 Tipo de empleo: Permanente Tiempo de trabajo: Full Time #J-18808-Ljbffr