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: https://www.fujifilm.com/us/en/about/region/careers
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 ([email protected]).
