Global Business Process Owner (GBPO) of Laboratory Controls na FUJIFILM Diosynth Biotechnologies

FUJIFILM Diosynth Biotechnologies :

We are a trusted CDMO partner for life. At FUJIFILM Biotechnologies, we encourage you to discover what inspires you every day, to follow your passion and your power – what we call Genki.

The work we do has the potential to transform people’s lives and to impact where it matters most. Each day is an opportunity to push the boundaries of your potential, so join us as Global Quality Control and become part of a fast-growing global company, united by Genki.

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:

Are you ready to step into the role as Global Business Process Owner (GBPO) for QC Laboratory Controls?

 

In this role you will set the strategic direction for our five FLB sites in US, UK and DK. This includes cascading process requirements across the global network and driving transparency, alignment and continuous improvement. In addition, you will have the ownership of the overall Policy for Laboratory Controls, including the document hierarchy and end-to-end process.

 

As a GBPO, you are the senior process Subject Matter Expert (SME) and leader with cross-site accountability and decision-making authority, overseeing up to 10 employees in a matrix organization.

 

Key Responsibilities

 

• Set the Strategic Direction: Define process strategy and provide guidance to sites.  Perform Regulatory Intelligence to ensure regulatory requirements are embedded in the process. Ensure Inspection Readiness of the process.
• Own the End-to-End Process: Create and maintain compliant global processes, build standardized processes, own global documents and ensure alignment with the QMS infrastructure. Develop process training structure for implementation at the sites.
• Cascade process requirements across the global network. Train and coach Local Process Owners. Develops a Global Community of Practice to provide framework for engagement and alignment across sites.
• Drive transparency, continuous Improvement and change. Encourage cross site collaboration.

Qualifications and Experience:

Qualifications & Experience

 

• M.S. degree or PhD within biotechnology, pharmacy, engineering or similar.
• Preferable a minimum of 15 years of experience within pharmaceutical industry (with GMP knowledge; FDA, EMA, MHRA).
• Proven managerial experience with people and project management.
• Expertise in developing and executing strategic agendas.
• Ability to communicate effectively with senior and executive leadership.
• Experience in presenting during regulatory inspections and customer audits.
• Capability to unify multiple sites and functions towards common objectives.
• Navigate ambiguity with risk management expertise.
• Proficient in both written and verbal communication.

Scope & Decision Making

 

•  Makes and influences decisions across the business and externally (eg: regulatory agencies, outsourced partners, etc...)
•  Able to work independently and with minimal direction.
• The GBPO will have a high sense of responsibility.
• Able to navigate in complex projects to influence QCs decision making.

Key Skills

 

• Knowledgeable of regulations driving the core business (e.g. FDA, EMA, MHRA).
• Expertise within their assigned process.
• Knowledgeable of systems supporting their process.
• Core understanding of integration and interactions with other processes.
• Basic knowledge of operations at each site.

Why work with us?:

At FDB, your passion – your Genki – is your power and we empower you to define what Genki means to you.

When you join us, we will train, develop and support you to become the best you can possibly be. We offer a structured new starter induction programme as well as on-going development training. In addition to this, we offer:

• Competitive salary plus company bonus scheme
• 35 days of holiday, plus bank holidays.
• Salary Sacrifice scheme offering, healthcare, bikes, dental etc.
• Generous pension scheme
• Free parking and electric charging points 

Closing date 22nd of September 2025

Candidatar-se agora