Job Description
PE Global is recruiting for an Associate Director - Quality Assurance on behalf of our biopharmaceutical client in Louth. This is a permanent role. A critical role within the QA organisation, theAssociate Directorwill lead the QA team. Responsible for ensuring that biologic drug substance manufacturing is performed in compliance to cGMP, site SOPs and controlled documents from end-to-end, covering warehouse and supply chain management operations, manufacturing operations, batch certification by QP, batch release and shipment for biologics drug substance. Responsibilities Lead the QA teams responsible for oversight of Warehouse and Supply Chain Management (SCM), Drug Substance Manufacturing Operations and the QA team responsible for batch disposition operations. Develop, implement, and monitor the quality systems relating to warehouse, SCM and manufacturing and batch disposition operations. Provide QA review and approval of SOPs, master batch records, quality risk assessments, change controls and other documentation, as applicable, associated with Manufacturing, Warehouse, SCM and batch disposition operations. Review and approve deviation reports, CAPAs, and technical documents to support GMP decisions and batch disposition. Ensure online QA presence in Warehouse and Manufacturing areas during operation, as required. Lead the GMP Release program. Liaise with internal and external teams, as appropriate, to ensure that all deviations, investigations, and batch record review comments are adequately addressed and closed out in a timely manner as defined in SOPs. Liaise with internal and external teams, as appropriate, to ensure that all CAPAs, change controls, internal audit observations are addressed and closed out in the required time frame. Ensure timely and efficient disposition of biologics drug substance batches. Supervise direct reports on a day-to-day basis, provide training and communications, assignment, and prioritisation of work. Manage performance, delivery of objectives and career development of direct reports. Ensure clear communication on issues and timely escalation as applicable. Support inspection/audit readiness activities, act as SME for QA DS function during regulatory inspections and Client audits, prepare responses to observations, monitor implementation of follow-up actions. Lead and/or represent QA on multidisciplinary teams including New Product Introduction (NPI), Technology Transfer and continual improvement projects. Perform internal and external audits, as required. Identify and drive opportunities for continuous improvement. Champion site metrics and KPIs to ensure targets are achieved, met and counter measures in place when applicable. Perform all duties in accordance with GMP requirements, SOPs and controlled documents. Flexibility to take on additional tasks and responsibilities at the discretion of the Senior Director of Quality. Education A Bachelors degree in a technical discipline (e.g., biochemistry, chemistry, engineering) would be an advantage. Knowledge/Experience Required: 7 plus years experience in the biotechnology and/or pharmaceutical industries within a Quality role, preferably in QA or similar. Candidates from Warehouse, Distribution (GDP) or Manufacturing Operations disciplines within the biotechnology and/or pharmaceutical industry will be considered but knowledge of Quality Management System, pharmaceutical regulations and continuous/process improvement tools will be required to be demonstrated. Experience managing a QA operations team would be an advantage. Experience in performing internal audits would be an advantage. Experience interacting the regulatory Inspectors would be an advantage. Experience working in a CMO in Client-facing role would be an advantage. Demonstrated knowledge of Quality Management System and continuous/process improvement tools. Personal skills Strong technical aptitude (i.e., able to read & comprehend technical documentation & execute procedures). Strong knowledge of cGxP requirements and regulations. Knowledge of troubleshooting and problem-solving skills, e.g., formal root cause analysis such as Ishikawa diagrams, FMEA etc. Demonstrated knowledge of Quality Management System and continuous/process improvement tools. Adaptable, able to multi-task and handle tasks with competing priorities effectively. Strong sense of urgency with a drive to close actions to closure on time and in full. Interested candidates should submit an updated CV. Please click the link below to apply, call Paul Wheatley on or alternatively send an up-to-date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: QA CAPA Biologics