The Role of GBPO for LABORATORY CONTROLS is defined by ownership of the overall Policy for Laboratory Controls, including the document hierarchy and end-to-end process: setting the strategic direction, cascading of process requirements across the network and driving transparency, alignement and continuous improvement in accordance with Veeva definition.  GBPOs are Process SMEs and Leaders with Cross Site Accountability and Decision Making Authority 

Key Accountabilities

• Own the End-to-End Process
• Create and Maintain compliant global processes
• Build standardized processes 
• Own global documents and ensure alignment with QMS infrastructure
• Develop process training structure for implementation at the Site
• Set the Strategic Direction
• Defines process strategy and provides guidance to Sites and Operations
• Performs Regulatory Intelligence to maintain visibility to emerging trends and regulations 
• Ensures regulatory requirements are embedded in the process
• Ensures Inspection Readiness of the process
• Ensures harmonization through understanding of unique Site pressures and requirements
• Cascade of process requirements across the Network
• Trains and coaches Local Process Owners on how to translate and deploy global process at the Site
• Develops a Global Community of Practice to provide framework for engagement and alignment across Site 
• Drive Transparency and Continuous Improvement
• Share issues and solutions across organizations and Sites
  Drive change and continuous process improvements through a single channel of accountability 
• Encourage cross Site collaboration 
• Own and communicate metrics that provide transparency of process performance

Experience & Qualifications

• M.S. degree or PhD within biotechnology, pharmacy, engineering or similar  

• Preferrable a minimum 10 years of experience within pharmaceutical industry (with GMP knowledge; FDA, EMA, MHRA):   

  • Ability to develop and implement a strategic agenda  
  • Ability to align multiple sites and functions on a common goal  
  • Ability to communicate effectively with senior and executive leadership 
  • Manages time effectively  
  • Ability to work on multiple deliverables in a deadline driven environment  
  • Ability to navigate ambiguity to drive solution  
  • Ability to lead across functional and across site teams  
  • Ability to translate regulations and customer requirements into process  
  • Ability to communicate risk and identify mitigations that consider cross functional and cross site impact  
  • Experience with implementation and/or change management of global IT systems within the life science domain.  
  • Experience presenting in regulatory inspections and customer audits  
  • Strong written and verbal communication skills

Scope & Decision Making

•  Makes and influences decisions across the business and externally (eg: regulatory agencies, outsourced partners, etc...)  
•  Able to work independently and with minimal direction 
• The GBPO will have a high sense of responsibility 
• Able to navigate in complex projects to influence QCs decision making

Key Skills

• Knowledgeable of regulations driving the core business (e.g. FDA, EMA, MHRA) 
• Expertise within their assigned process
• Knowledgeable of systems supporting their process
• Core understanding of integration and interactions with other processes
• Basic knowledge of operations at each site