Welcome page Returning Candidate? Log back in! Global Business Process Owner (GBPO) of Laboratory Controls Job Locations US-NC-Holly Springs Posted Date 11 hours ago(8/28/2025 4:54 AM) Requisition ID 2025-35330 Category Quality Control Company (Portal Searching) FUJIFILM Biotechnologies Position Overview

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 

Job Description

Key Accountabilities

Own the End-to-End Process Create and Maintain compliant global processesBuild standardized processes Own global documents and ensure alignment with QMS infrastructure Develop process training structure for implementation at the SiteSet the Strategic Direction Defines process strategy and provides guidance to Sites and OperationsPerforms Regulatory Intelligence to maintain visibility to emerging trends and regulations Ensures regulatory requirements are embedded in the process Ensures Inspection Readiness of the processEnsures harmonization through understanding of unique Site pressures and requirementsCascade of process requirements across the Network Trains and coaches Local Process Owners on how to translate and deploy global process at the SiteDevelops 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 processKnowledgeable of systems supporting their processCore understanding of integration and interactions with other processesBasic knowledge of operations at each site  Options Apply for this job onlineApplyShareEmail this job to a friendRefer Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed Application FAQs

Software Powered by iCIMS
www.icims.com