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
As a Junior QC IT Systems Analyst you will be responsible for operations and maintenance of the systems in your domain particularly Labware LIMS and Empower. Your key objective will be to continuously improve business operations and to ensure compliance/alignment between the different requirements at different levels and from different stakeholders of the organization. | | You will work with the vendors and help coordinate all updates to the systems, report and track technical issues, proactively manage licenses of the systems, as well as providing second level support of the system, maintain a knowledge base for first level support as well as promote best practices in the application utilization. | | The role also includes smaller project management tasks including supporting upgrade projects, operations management, participate as a subject mater expert in Global IT and compliance projects, initiate and drive own improvements in cooperation with vendor if required. You would be responsible for supporting the maintenance of the validated state of the systems throughout the life cycle. This role requires developing and documenting the technical knowledge and transferring technical knowledge to peers and the business. | | Key Responsibilities | | - Provision of timely and effective support to ensure the satisfaction of internal customers. Understand and anticipate the needs to enhance the quality-of-service delivery. | - Responsible for ensuring the reliability, availability, and security of systems/technologies under your management. Keeping up to date with technological advancements and implementing system and process improvements in your area | - Adherence to ITIL or relevant IT service management (ITSM) frameworks is expected, along with the responsibility for documenting and refining IT processes to increase operational efficiency and effectiveness. | - Compile technology related documentation for GxP and critical IT technologies. Participate in system validation and testing processes as required. Approve validation documentation together with relevant IT QMS documentation | - Manage or contribute to IT projects, ensuring they meet deadlines and stay within budget. Employing best practices in project management | - Establishing and maintaining relationships with technology vendors and service providers. Managing vendor performance to ensure the company receives value from them. | - Support and administer any applications that are added to the Technical Operations QC IT group portfolio | And other job duties that may be assigned from time to time. | | Knowledge & Skills | | - Excellent oral and written communications skills and fluency in English | - Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals | - Pharmaceutical experience is required | - Ability to prioritize and work autonomously based on common goals and objectives. | - You have a strong analytical mind, eye for detail and problem-solving skills. You have a natural drive for simplification. | - Quality minded | - Strong analytical skills | - High sense of responsibility. | - Willingness to learn new things | - Experience with QC and QA processes is an advantage | - Working knowledge of software maintenance in a regulated environment. Documented ISO and cGMP understanding and knowledge of GAMP | - Experience in IT projects
- Production support for OT issues | - Recipe configuration and management | - OT system administration | - Support for CI activities | - Support operator training
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
- Lead FUJIFILM Biotechnologies cash management strategy | - Analyze inputs affecting cash flow such as capex, opex, working capital, and inventory, and communicate these insights to the leadership | - Develop and lead CCC improvement initiatives across the organization (from order to cash) | - Implement efficient and accurate tracking of cash flows across various projects and sites, ensuring comprehensive oversight at FUJIFILM Biotechnologies | - Responsible for the cash management strategy and providing overview/roadmap across the entire FUJIFILM Biotechnologies organization to ensure improvement in this area. | - Providing suggestions/oversight to FUJIFILM Biotechnologies leadership and company stakeholders during this growth trajectory. | - This position is working Hybrid and will be performed these responsibilities within location to a FUJIFILM Biotechnologies site, and will require travel to the others sites 20-30%
As a global finance business partner you will be responsible for the cost controlling and partnering of Fujifilm Biotechnologies global cost areas with a focus on IT, Quality and Science and Innovation. You will play a key role in the budgeting, forecasting, monthly reporting and financial planning processes to ensure alignment with objectives and cost optimization opportunities. In your partnering role you will collaborate and drive performance through transparency of data facilitating accountability and self-service for cost owners as well as providing guidance on governance processes. | | - Be a Strategic Partner: play a key role in the budgeting, forecasting, and financial planning processes related to global costs areas, ensuring alignment with global objectives and identifying opportunities for cost optimization. | - Global cost controlling: Lead the cost controlling for specific global cost areas including global IT, Quality and Science and Innovation. Work closely with the Global IT Finance Business controller providing guidance on cost control, opportunities and cost optimization. Additionally liaise with all FDB sites to ensure accuracy of the data reported. | - Global capex project controlling and partnering: Lead the cost control of global capex projects initiated by global functions, with a particular emphasis on global IT, while also encompassing other relevant global functions as appropriate. Provide guidance and support throughout the project governance and approval process, ensuring that business cases supporting the request are robust and underpinned by a comprehensive financial rationale. Serve as a representative of global finance on the IT portfolio board and in other business forums as needed. Ensure that global projects are accurately budgeted and accounted for at FDB sites, adhering to relevant accounting standards and policy. | - Drive Performance with Data: Analyse financial results, spot trends, and provide insights that empower leadership to make data-driven decisions. Drive accountability to global cost owners through meaningful, transparent data, ability to self-serve, as well as providing finance business partnering to these functions. Provide transparency through reporting the total cost of global functions including local and global costs. | - Tell the Story Behind the Numbers: Prepare and present reports, business cases, and performance analyses—turning complex data into clear, actionable insights for leadership | - Process Improvement: Strive for continuous improvement supporting the enhancement of finance processes, systems and tools for great accuracy, efficiency and compliance | *#LI-Hybrid
- Develop and continuously maintain an updated modality strategy based on market insights, detailing and recommending where FDB should position itself and how to grow profitability within the modality. | - Provide insights on market, competitors, and customer needs to identify business synergies, opportunities, dependencies, improvements, market expansions, or acquisition targets that address roadmap strategy and provide a competitive advantage within the modality. | - Ensure all operational, marketing and commercial efforts are aligned, customer-centric and deliver value to the target audience and meet sales and profitability goals. | - Present business case, strategy, and future roadmap recommendations, to the Strategy Decision Forum and ELT for input and approval, including investment requirements. | - Collaborate with cross functional teams to ensure successful prioritization and implementation of aligned tactics in support of the approved modality strategy and roadmap. Develop and socialize a launch playbook to train internal teams on the approved strategy and tactics. | - Ensure organizational alignment between the modality strategy, kojoX and our Partners for Life strategies. | - Ensure modality roadmap priorities reflect and are revised for continuous improvement to account for market, customer and competitive insights. Ensure roadmap priorities are reflected in innovation, business development, and marketing strategies. | - Define, deliver, and optimize modality strategy value proposition with the Marketing and Commercial teams to ensure alignment with customer segmentation, go-to-market strategy and tactics. Create evidence-based proof points and case studies that differentiate our offerings. | - Collaborate with our Business Development team on business expansion initiatives; perform gap analyses to determine where the Company can become more competitive and how we strengthen our overall business strategy. | - Support the development and implementation of dedicated marketing and commercial strategies that align with the overall modality strategy and business goals. Collaborate with commercial to ensure a robust sales pipeline that can fill the service line manufacturing capacity (short, mid, and long term). | - Participate in strategic commercial dialogues with key partners and provide technical expertise to sales teams and customers as needed. | - Create, maintain, and continuously improve modality roadmaps to ensure alignment with market, customer and competitive insights, capacity of operational footprint and budgets. | - Drive P/L (Revenue, ROS, PM, EBITDA etc.) transparency and insights for continued financial performance improvement. | - Track and report operational performance (KPIs) to ensure high customer trust and satisfaction. | - Collaborate as needed to develop key areas of improvement and focus to deliver the Partners for Life strategy, with an ongoing engagement of and partnership with ELT. | - Provide modality strategy and life cycle management and lead new service line offering development through leadership of a cross-functional team. | - Perform other activities as assigned. |