Global Business Process Owner for LIMS

FUJIFILM Diosynth Biotechnologies U.S.A., Inc.; Billingham; On-site; GBP 60,000 - 90,000; Full time

Job summary

FUJIFILM Diosynth Biotechnologies is seeking a Global Business Process Owner for QC LIMS in Billingham. This role is vital for the strategic direction, process ownership, and continuous improvement across their quality control operations. The ideal candidate will have a strong background in the pharmaceutical industry, with proficiency in global IT systems implementation and regulatory requirements. Join a dynamic company dedicated to improving lives through innovative biopharmaceuticals.

Benefits

Equal employment opportunities

Training and development opportunities

Qualifications

• At least 10 years of experience within the pharmaceutical industry (with GMP knowledge).
• Experience with implementation and/or change management of global IT systems within the life science domain.
• Strong written and verbal communication skills.
• Ability to develop and implement a strategic agenda.

Responsibilities

• Own the End-to-End Process and maintain compliant global processes.
• Define process strategy and provide guidance to Sites and Operations.
• Train and coach Local Process Owners on global process deployment.
• Drive transparency and continuous improvement across the organization.

Skills

Communicating effectively with senior leadership

Change management

Time management

Leading cross-functional teams

Understanding of regulations (FDA, EMA, MHRA)

Education

M.S. degree or PhD in biotechnology, pharmacy, engineering or similar

Job description

FUJIFILM Diosynth Biotechnologies

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.

About Us

We are a dynamic global company and our focus is to combine technical leadership in cell culture, microbial fermentation and gene therapies with world class cGMP manufacturing facilities to advance tomorrow’s medicines.

With sites in Billingham & Wilton UK, Hillerod Denmark, North Carolina and Texas USA, the size and breadth of our business will open up huge opportunities for you, whether you want to move to a different role in the UK, relocate, or progress and take on more responsibility.

Our teams are proud to partner with innovative companies reimagining what’s possible in biopharmaceuticals. Every day at FDB is a day for improvement, each challenge is an opportunity for growth, and every moment is a chance to evolve together.

Role & Responsibilities

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

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

Qualifications and Experience

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

Why work with us?

EEO Information

Fujifilm is committedto 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 ([e-mail]).