Global Business Process Owner (GBPO) of Laboratory Controls

Fujifilm

  • Billingham, County Durham
  • Permanent
  • Full-time
  • 7 days ago
FUJIFILM Diosynth Biotechnologies :We are a trusted CDMO partner for life. At FUJIFILM Biotechnologies, we encourage you to discover what inspires you every day, to follow your passion and your power – what we call Genki.The work we do has the potential to transform people’s lives and to impact where it matters most. Each day is an opportunity to push the boundaries of your potential, so join us as Global Quality Control and become part of a fast-growing global company, united by Genki. About Us:We are a dynamic global company and our focus is to combine technical leadership in cell culture, microbial fermentation and gene therapies with world class cGMP manufacturing facilities to advance tomorrow’s medicines.With sites in Billingham & Wilton UK, Hillerod Denmark, North Carolina and Texas USA, the size and breadth of our business will open up huge opportunities for you, whether you want to move to a different role in the UK, relocate, or progress and take on more responsibility.Our teams are proud to partner with innovative companies reimagining what’s possible in biopharmaceuticals. Every day at FDB is a day for improvement, each challenge is an opportunity for growth, and every moment is a chance to evolve together. Role & Responsibilities: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
Qualifications and Experience: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
Why work with us?:At FDB, your passion – your Genki – is your power and we empower you to define what Genki means to you.When you join us, we will train, develop and support you to become the best you can possibly be. We offer a structured new starter induction programme as well as on-going development training. In addition to this, we offer:
  • Competitive salary plus company bonus scheme
  • 35 days of holiday, plus bank holidays.
  • Salary Sacrifice scheme offering, healthcare, bikes, dental etc.
  • Generous pension scheme
  • Free parking and electric charging points
Closing date 22nd of September 2025

Fujifilm