Sr Quality Lead Brazil

At UCB, we put our heart, soul, and skills into making a difference for people living with severe diseases. Working together to push boundaries, we combine the best of our talents to unlock innovation. Will you join us on our pioneering journey? To strengthen our team, we are looking to fill the position of **Quality Manager Brazil.****Key Responsibilities**:- Facilitate, implement and maintain an effective and compliant QualityManagement System in line with the Market Quality strategy and accordingto UCB policies, corporate quality standards, global SOP’s, cGxP andapplicable local regulatory requirements.- Address any deficiencies identified through audits or other meanproviding guidance for identification and timely implementationappropriate corrective and preventive actions.- Ensuring the execution, and having the oversight, of the local QualityManagement System, e.g.- Management of complaints, deviations, change controls and CAPAaccording to UCB corporate SOPs and using the relevant UCBelectronic systems; including oversight of KPIs- Execution of the periodic Management Review to assureconsistency and compliance with UCB procedures and localregulations, and to ensure escalation to management of (potential)issues;- Periodic Product Quality Review in accordance with the MAHresponsibility;- Quality oversight to Local GxP Vendors in compliance with UCBQuality Standards and ENG guidance (qualification, qualiagreements, vendor management, divestment). Approving anysubcontracted activities impacting GDP or GMP at the affiliat- Establish and adhere to self-inspection and external audit plans;- Lead local recalls and all related correspondence with nationalcompetent authorities.- Ensure all Quality deliverables are completed in a timely manner inaccordance with Global SOPs (e.g., follow up and closure on all relevantcomplaints, deviations and CAPAs, change controls).- Support Market Quality in defining the appropriate organization of the araccording to UCB strategic plans, identify the right talents and appropriateresources to achieve quality compliance in line with UCBs vision andstrategy. Develop the skills, capabilities and expertise of the talents in theteam across the area. Define and document roles and responsibilities fthe area, through job descriptions, inter-country agreements, In-MarketQuality procedures, as appropriate.- Ensure efficient information flow and effective communication ofrelevant quality matters within the relevant Affiliate organization, from tTerritory to the Global QA organization and vice-versa including but notlimited to issue escalation and communication of new regulations via theRegulatory Intelligence Network (RIN).- Ensure the establishment of a business continuity plan for Quality activities.- Represent the area in Market Quality meetings, Market Quality and GlobalQuality projects and improvement initiatives, as requested.- Actively engage in the Affiliate Risk to Value process, collaborate with kGxP and business stakeholders to identify and assess risks, and support thelocal risk champion in risk mitigation activities. Together with sitemanagement provide direction, formulate strategies and make decisionswhich ensure efficient Quality operations and Quality risk mitigatio- Ensure compliance to GDP and ensure proper shipping conditions areimplemented for secondary and tertiary distribution, as applicable, drivinga QA decision on the disposition of the product in case of deviations(including excursions).- Ensure readiness for all cGxP internal, external and regulatory inspections.- Ensure training is timely performed and documented for Local Qualityorganization.- Maintain the Site Master File and/or Quality Manual, as required.- Ensure that the Intra-group quality agreement with Global QA andassociated appendices are complete and up to date.- Ensure appropriate systems in place at the Affiliate to ensure produtraceability of all products.- Keep records of any delegated GDP or GMP duties at the affiliateneeded.- Ensure compliant final disposition of returned, rejected, recalled or falsiproducts and authorization of return to saleable stock of any returnedmedicinal products.- Ensure any additional requirements imposed on controlled or un-licensedmedicinal products by national law are adhered to.- Maintain competence in GDP and GMP through regular training.- Ensure the analysis is carried out in Quality Control and in third parties in atimely manner according to applicable UCB standards and procedures,GMP and applicable local regulatory requirements.- Ensure the facilities and the equipment of the Quality Control laboratory isproperly maintained according to applicable UCB standards andprocedures, GMP and applicable local regulatory requirements.Pharmaceutical Responsible:Act as the Pharmaceutical Responsible for UCB Brazil and CRF according tocurrent GMP/GDP guidelines, local laws