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 OverviewThe 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: https://www.fujifilm.com/us/en/about/region/careers
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 processes
Build standardized processes
Own global documents and ensure alignment with QMS infrastructure
Develop process training structure for implementation at the SitesSet 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 requirementsCascade 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 SiteDrive 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 & Experience
M.S. degree or PhD within biotechnology, pharmacy, engineering or similarPreferrable 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 auditsStrong written and verbal communication skillsAbility to communicate effectively with senior and executive leadershipAbility to develop and implement a strategic agendaAbility to align multiple sites and functions on a common goalManages time effectivelyAbility to work on multiple deliverables in a deadline driven environmentAbility to navigate ambiguity to drive solutionAbility to lead a cross functional and cross site teamsAbility to translate regulations and customer requirements into processAbility to communicate risk and identify mitigations that consider cross functional and cross site impactScope & Impact
Make and influences decisions across the business and externally (eg: regulatory agencies, outsourced partners, etc...)Able to work independently and with minimal directionHigh sense of responsibilityAble 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 processExpertise in systems supporting their processCore understanding of integration and interactions with other processesBasic 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 InformationIf 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 (fdbglobaltalent@fujifilm.com).
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 FAQsSoftware Powered by iCIMS
www.icims.com