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Within the Global Quality Systems and Compliance team, Supplier Management provides overall quality oversight of inter and intra company suppliers who provide a service or material to Seqirus (including suppliers of direct materials, distribution & logistics and GMP services).
Job responsibilities: * Follow the strategy, standards, global processes and procedures for supplier introduction and monitoring. * Support implementation and closure of supplier change notifications * Provide support and expertise for global sites for any quality issues encountered from suppliers * Facilitate root cause analysis and corrective actions of supplier quality issues (deviations) and support through on-site supplier visits, if applicable, for root cause analysis and verification of correction actions of supplier quality issues * Develop and report on supplier quality Key Performance Indicators (KPIs) driving to optimize performance, collation of supplier quantitative data for supplier risk assessments and prevent occurrence of any non-conformity relating to product, process or system. Quality Partnerships * Support Operations, Supply Chain, Supply Chain QA, Procurement and QA leaders with the qualification and management of suppliers and service providers to ensure they consistently meet GxP requirements of Seqirus. * Represent Supplier Management in cross-functional teams to develop successful partnerships for consistent GxP-compliant supplier oversight. * Partner with the Quality Compliance Auditing/Inspections team to ensure any requested data is available to support external audits. * Represent Supplier Management in external audits by regulators/customers and ensure any Supplier Management related observations are addressed appropriately and timely. Support remedial actions (e.g. CAPA) with operational areas of the business. * Collaborate with Seqirus sister sites in US and Australia to ensure best practices and robust processes/procedures are in place. * As required, provides training on Supplier Quality Management processes to other functions. Continuous Improvement * Identify, develop and implement strategic quality initiatives to ensure continuous improvement with respect to supplier quality performance. Regulatory Intelligence * Acquire and maintain knowledge of current local and international regulatory and legislative requirements/trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters are provided to the sites.
Minimum Education Requirements
* Bachelor's degree in science or engineering related discipline. Advanced degree a plus. Minimum Experience Requirements * Minimum of 3 years of engineering, manufacturing, or quality experience in regulated industry, biotech/pharmaceutical industries preferred. * Demonstrated experience of problem solving techniques within a Supplier Management/Supplier Quality environment * Demonstrated ability to lead complex investigations/deviations * In depth knowledge of the regulatory environment for the manufacture of drugs. * Knowledge of global cGMP regulations and ISO standards preferred * Demonstrated ability to understand data sets and drive to data-based decision * Ability to travel globally up to 10%
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.