Global External Operations Specialist

PSC Biotech is hiring on behalf of our biopharmaceutical client a global leader in developing and delivering innovative therapies that make a meaningful difference for patients living with serious and life-threatening rare genetic diseases

The GEO Operations Specialist will be a key member of the Global External Manufacturing Operations team which plays a vital role in supporting external contract manufacturing activities for both commercial and clinical drug products.

In this position the specialist will provide direct support to the GEO Operations Managers and Process Team Leads who ensure a reliable and uninterrupted product supply from Contract Manufacturing Organizations (CMOs). The successful candidate will collaborate across multiple process teams and product modalities to manage and execute ERP and QMS transactional activities as well as perform other essential operational support functions. This role reports directly to the Director of Operations GEO. Work style is hybrid (2days office).

• Provide 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 at 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.
  

• Minimum requirement of 5 years experience within an Operations and regulated environment.
  
• Relevant 3rd level qualification.
  

Requirements

• 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.