Global Business Process Owner (GBPO) of Laboratory Controls

Fujifilm-posted 4 months ago

Holly Springs, NC

Machinery Manufacturing

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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, alignment and continuous improvement in accordance with Veeva definition. GBPOs are Process SMEs and Leaders with Cross Site Accountability and Decision Making Authority.

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
Define process strategy and provide guidance to Sites and Operations
Perform Regulatory Intelligence to maintain visibility to emerging trends and regulations
Ensure regulatory requirements are embedded in the process
Ensure Inspection Readiness of the process
Ensure harmonization through understanding of unique Site pressures and requirements
Cascade of process requirements across the Network
Train and coach Local Process Owners on how to translate and deploy global process at the Site
Develop 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

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

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Global Business Process Owner (GBPO) of Laboratory Controls

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