Global Business Process Owner for LIMS

The work we do at FUJIFILM Biotechnologies (FB) has never been more important and we are looking for talented candidates to join us. Were growing our capabilities and looking for passionate mission-driven people like you who want to make a real difference in peoples lives. Join FDB and help create the next vaccine cure or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here youll work alongside and learn from some of the most dedicated scientists engineers and manufacturers in the industry. Were proud to cultivate a culture that will fuel your passion energy and drive. This is what FDB calls Genki.

Join us and discover a community that thrives on diversity and never scares away from a complex challenge. Take the opportunity to work with some of the most dedicated scientists engineers and manufacturers in the industry. At FDB you determine whats possible.

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 tomorrows 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 whats 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.

The Role of the Global Business Process Owner for QC LIMS is defined by: Ownership of the end-to-end process setting the strategic direction cascading of process requirements across the network and driving transparency and continuous improvement in accordance with Veeva definition.

GBPOs are Process SMEs and Leaders with Cross Site Accountability and Decision Making Authority. This role will have 0 direct reports and up to 10 indirect reports.

Key Responsibilities:

• 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 Sites
• 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

Scope & Impact

• Make and influences decisions across the business and externally (eg: regulatory agencies outsourced partners etc...)
• Able to work independently and with minimal direction
• High sense of responsibility
• Able to navigate in complex projects to influence QCs decision making

Key Knowledge

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

Qualifications & Experience

• 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) and IT systems including:
• 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
• Ability to communicate effectively with senior and executive leadership
• Ability to develop and implement a strategic agenda
• Ability to align multiple sites and functions on a common goal
• Manages time effectively
• Ability to work on multiple deliverables in a deadline driven environment
• Ability to navigate ambiguity to drive solution
• Ability to lead a cross functional and cross 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