Quality Assurance And Distribution Senio
PE Global are currently recruiting for a Quality Assurance and Distribution Senior Manager for one their biopharmaceutical clients in Cork. This is a permanent role. Responsibilities of the role: Direct management of two Associate Managers, responsible for mentoring & coaching the individuals to support them in their day-to-day roles & their career development. Collaborate cross-functionally and geographically with stakeholders including Supply Chain, Commercial Operations, Corporate Quality, Customer Service and Manufacturing to ensure that product distribution processes are aligned to the regulatory requirements and the needs of the company and its customers, ensuring best practice, compliance and alignment with business needs. Deliver Quality support to partners across Europe to drive standardized approach to ensuring compliance with relevant GMP and GDP regulations. Drive compliance in 3rd party distributor markets for both Commercial and Access products by implementing effective Quality Agreements and supporting routine operations from a Quality perspective. Ensure that Quality Systems and practices are developed and implemented across contracted third-party logistics providers (3PLs), contracted distributors and other service providers engaged in any aspect of distribution of the company’s products, in accordance with relevant GMP & GDP regulations. Deputise for the Associate Director Quality-Distribution in all aspects of responsibility, as required. Perform as the Quality representative for initial due diligence & on-boarding of new affiliates & distributors. Deliver an effective GDP training programme. Develop & manage Key Performance Indicators to track GDP compliance across related operations. Conduct and serve as a lead/co-ordinator of investigations and corrective and preventative action (CAPA) recommendations related to distribution activities. Lead inter-site global projects in the area of distribution of APIs and Finished Products. Participate in internal and external compliance and for-cause audits to meet business’ needs. Perform the annual product recall challenge & participate in product recall, as required. Present to Senior Management on aspects of Quality in the supply chain, as required. Education and Experience Required: BA or BS degree, preferably in a scientific discipline. 5 years experience within the Pharmaceutical industry. Demonstrate strong leadership skills, mentoring and coaching individuals and creating a learning culture that enables individuals to reach their maximum potential and builds the capability of the organization. Knowledge of Six Sigma, Define-Measure-Analyse-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods is beneficial. If you are interested in this position, please forward your CV to firstname.lastname@example.org or call Catherine on 0214297900. This job originally appeared on RecruitIreland.com.
160 days ago