Global Business Process Owner for LIMS

Position Overview

The work we do at FUJIFILM Biotechnologies (FB) has never been more important and we are looking for talented candidates to join us. We’re growing our capabilities and looking for passionate, mission-driven people like you who want to make a real difference in people’s 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, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re 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 what’s possible.

Company Overview

The work we do at FUJIFILM Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Biotechnologies and help make the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what we call Genki. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit:

Job Description

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 ProcessCreate and Maintain compliant global processesBuild standardized processesOwn global documents and ensure alignment with QMS infrastructureDevelop process training structure for implementation at the Sites

Set the Strategic DirectionDefines process strategy and provides guidance to Sites and OperationsPerforms Regulatory Intelligence to maintain visibility to emerging trends and regulationsEnsures regulatory requirements are embedded in the processEnsures Inspection Readiness of the processEnsures harmonization through understanding of unique Site pressures and requirements

Cascade of process requirements across the NetworkTrains 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 ImprovementShare issues and solutions across organizations and SitesDrive change and continuous process improvements through a single channel of accountabilityEncourage cross Site collaborationOwn and communicate metrics that provide transparency of process performance

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

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

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ().

FUJIFILM Biotechnologies