Global Business Process Owner for QC LIMS

Global Business Process Owner for QC LIMS

Are you ready to step in to The Role of the Global Business Process Owner for QC LIMS, a role 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

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

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.

FUJIFILM Biotechnologies Denmark is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.

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.

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