Global External Operations Specialist

Our Biopharmaceutical client is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. They target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. The GEO Operations Specialist role will serve as an integral member of the Global External Manufacturing Operations team who have responsibility for and play a key role in supporting external contract manufacturing activities relating to commercial & clinical drug products. He/She will directly support the GEO Operations Managers/Process Team Leads who are responsible for ensuring seamless supply of product(s) from the contract manufacturing organizations (CMO). This candidate will be required to work across a number of multi-modality process teams to manage and execute ERP, QMS transactional activities as well as other support tasks. The GEO Operations Support role will report to the Director of Operations, GEO.ResponsibilitiesProvide direct support to Process Team Leads across Commercial & Clinical products (Small Molecules, Biologicals, Drug Substance, Drug Product and Packaging operations on targeted/prioritized activities.Manage and execute all transactional ERP aspects for production efforts at CMOs (includes executing production transactions, updating work order dates, receipting of purchase orders, inter organizational transfers etc.)Own and manage prioritized change controls and deviations within the Quality Management System (QMS) to effective on time closure and no impact on supply.Consolidation and issuance of key performance metrics per Process Team Provide back-up support for Process Team Leads where necessary (e.g. holidays)Support selected continuous improvement activities aligned to the site business plan objectives with clear and measurable time and money savings. Work cross-functionally to perform rigorous root cause analysis, to understand issues and implement corrective actions as appropriate. Document key business processes in a standard format (e.g., Best Practice Document or Standard Operating Procedure). There may be a need for this person to execute operation tasks with a view to eliminating or reducing the number of touchpoints associated with a task. This list of support responsibilities may change depending on business needs and employees are expected to be adaptable and flexible where this need arises.EXPERIENCE & Skills:Minimum requirement of 5 years’ experience within an Operations and regulated environment.Relevant 3rd level qualification.Required skills needed to accomplish the responsibilities/essential functions include:Will have a working understanding of ERP systems (e.g. SAP)Will have a good working understanding of the processes/unit operations assigned to the team. Ability to engage cross functional teams in the resolution of short-term issues and sustained performance for long-term goals.Experience in lean/six sigma/continuous improvement tools and techniques. Excellent written and verbal communication skills.A high level of initiative and drive, as well as excellent organizational skills, are key role requirements.Ability to work independently.