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Business Process Owner, PD ELN at FUJIFILM

Business Process Owner, PD ELN

FUJIFILM Durham, NC Full-Time

As part of the Fujifilm Diosynth (FDB) Transformation Centre of Excellence, the Global Business Process Owner, PD ELN will own the business processes associated with the IDBS E-Workbook platform, tracking and communication of data and KPIs associated with project goals and performance. The individual in this role will report to the Head of Transformation and will be collaborating with vendors and FDB teams to influence their roadmap and system improvements. They will also take ownership of associated SOPs, WIs, and eLearning/training materials, partake in global committees to promote and ensure alignment across sites, and manage and/or play a significant role in the delivery of projects which are linked with the usage or improvement of the platform. This role will involve strategic matrix projects which will include to varying degrees- global, multi-site, significant third-party involvement, and strategic client collaborations. The post holder will have direct reports in the organization to help manage development support of systems and the delivery of business change dependent on the platform (non-customer facing projects).

MAJOR ACTIVITIES AND RESPONSIBILITIES:

  • Gather and analyze data on PD ELN platform and associated systems to confirm fit with current ways of working across all assets on site.

  • Monitor to ensure proper usage of system and adherence to platform guidelines

  • Tracking and communication of data and KPIs associated with project goals

  • Ownership and maintenance of PD ELN platform and associated documentation (e.g., business processes, training, SOPs, WIs)

  • Manage the development, delivery, and maintenance of training across sites (e.g., eLearning, drop-in sessions, workshops)

  • Manage the PD ELN ServiceNow Forum

  • Working with the site teams to confirm correct user account creation and routine auditing of user accounts (correct role assignment, deactivation of recent leavers).

  • Collaborate with and assess performance of vendors and report to the global committee and System Owner

  • Lead the FDB PD ELN Spreadsheet Designer team

  • Supporting and coaching super users and end users in use of the system and across the PD ELN landscape

  • Monitor and work with site teams to collect improvement requests from end users

  • Review and consolidate improvement requests. Understand and standardize site requirements across assets.

  • Act as global champion to assess impact of proposed changes to the platform at global committee.

  • Global communication of platform updates, providing local support sessions if/when required.

  • Ownership of global change control and ticket hotline systems. Supporting change controls in the quality system.

  • Working with cross functional teams to ensure regulatory compliance (CSV, IT, QA, Regulatory, eQMS).

  • Communication of planned downtime (global level).

  • Collaboration across sites and with IDBS to influence updates and roadmap steer.

  • Leads investigations related to failures / issues to establish root cause.

  • Implementation of CAPAs to improve future ways of working.

  • Interacts with customers and regulatory agency personnel during visits and audits.

  • Works with any audit team for audit readiness for the platform.

  • Liaise with CSV teams to plan any system validation activities

BACKGROUND REQUIREMENTS:

Education/Experience:

  • Bachelors Degree with 8+ years experience in biopharmaceutical development

  • Advanced level experience with IDBS platforms and spreadsheet design

  • Experience with delivering training and managing matrix-based teams

  • Experience with laboratory inventory design and logistics

  • Experience using a wide range of project management tools and techniques

  • Change management experience

  • Excellent written and verbal communication skills

  • Proven ability to influence, negotiate and persuade, across a matrix organization

  • The GBPO should have a broad knowledge of biomanufacturing prep, execution, and analytical activities in relation to execution and test records, to help make informed decisions.

The ideal candidate will have the following knowledge, skills and aptitude:

  • Excellent written and verbal communication skills

  • Ability to influence, negotiate and persuade, especially at a senior level

  • Ability to present complex information in a clear and concise manner

  • Ability to provide leadership to a team

  • Ability to effectively prioritize

  • Ability to adjust personal style when dealing with different individuals

  • Essential experience: >8 years of relevant experience in the biopharmaceutical area and a personal network of contacts in this industry

  • Insight in / experience with emergent technologies

  • Proven ability to write business and quality documents

  • Proven presentation skills

  • Ability to work effectively and lead in teams

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 130 and Export Administration Regulations in 15 C.F.R. Part 730 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Companys ability to secure an export authorization.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please e-mail [ Email address blocked ] - Click here to apply to Business Process Owner, PD ELN.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Requisition ID: 2022-21402

External Company URL: [ Link removed ] - Click here to apply to Business Process Owner, PD ELN

Street: 6051 George Watts Hill Drive

Recommended Skills

  • Analytical
  • Auditing
  • Biopharmaceuticals
  • Business Processes
  • Business Transformation
  • Change Management
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