FUJIFILM Diosynth Biotechnologies
We are a trusted CDMO partner for life. At FUJIFILM Diosynth Biotechnologies (FDB), 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 Quality Facility Manager 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
* Facility leadership: To represent Quality within the manufacturing asset with daily GEMBAs, regular inspections and assessment of all areas used for GMP manufacturing.
* Facility ownership and execution: Responsible for ensuring the manufacturing facility is maintained at all times to the required clean room standards, is fit for manufacturing GMP product within and is maintained in accordance with the FDBK PQS and the relevant global regulations.
* Facility audits/inspections: To ensure that facility documentation (for example logbooks, forms) are continuously improving and are audit/inspection ready at all times, with operational risks minimised whenever possible.
* Support the satisfactory completion of client audits and regulatory inspections.
* Support project and site inspection readiness activities and to host or present during client audit and regulatory inspections as directed.
* Continuous improvement: To ensure that documented reviews take place to identify any required improvements, including operational improvements. To ensure that these improvements are effectively and quickly implemented.
* Leadership: To lead designated quality activities in a professional manner, demonstrating effective leadership qualities. To identify, tackle and resolve issues in an appropriate way.
* Management: To manage day-to-day activities effectively, showing excellent planning, communication, delegation and timekeeping abilities. To build constructive working relationships with internal and external customers, based on trust, ethics, professionalism and delivery.
Qualifications and Experience
* Qualified to Degree level and have approximately 5 years’ experience in a Quality role and greater than 2 years’ experience in a regulatory environment (GMP/GLP).
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 4th April 2025
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