Quality Facility Manager

at  Fujifilm Diosynth Biotechnologies

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 a 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 the Quality assessment of standard adherence within the manufacturing facility. Assess that the required clean room standards are adhered to, is fit for manufacturing GMP product within and in accordance with the FDBK PQS and the relevant global regulations. Stop manufacturing activities if assessment highlights serious GMP breaches and escalate to Senior QA and Operational Management
• Facility communication: To identify, communicate and escalate identified operational risks in a timely manner and to resolve or mitigate or minimise when possible
• 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
• Investigations champion: To lead, aid or approve environmental, utility or cleaning investigations. To assess any environmental or utility breaches and/or adverse trends and manage the reporting and assessment of risk for said breaches or trends. Ensure that the correct investigational pace is set and that appropriate tools are used e.g. fishbone, RCA, 5-Whys. To ensure that outcomes are valid and that CAPA actions are appropriate
• Quality documentation: To effectively manage the generation and approval of key Quality documentation to support manufacture of product. To ensure that the documentation is fit-for-purpose and is designed to minimise errors

Qualifications and Experience:

• Microbiology/Chemistry/Biochemistry Degree
• A minimum of 8 years’ experience of a GMP manufacturing facility
• Experienced in the application of the Pharmaceutical Management System
• Able to assess clean room standards
• Practical knowledge and experience in pharmaceutical/GMP environments, including assessing and understanding complex issues

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

• 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 the Quality assessment of standard adherence within the manufacturing facility. Assess that the required clean room standards are adhered to, is fit for manufacturing GMP product within and in accordance with the FDBK PQS and the relevant global regulations. Stop manufacturing activities if assessment highlights serious GMP breaches and escalate to Senior QA and Operational Management
• Facility communication: To identify, communicate and escalate identified operational risks in a timely manner and to resolve or mitigate or minimise when possible
• 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
• Investigations champion: To lead, aid or approve environmental, utility or cleaning investigations. To assess any environmental or utility breaches and/or adverse trends and manage the reporting and assessment of risk for said breaches or trends. Ensure that the correct investigational pace is set and that appropriate tools are used e.g. fishbone, RCA, 5-Whys. To ensure that outcomes are valid and that CAPA actions are appropriate
• Quality documentation: To effectively manage the generation and approval of key Quality documentation to support manufacture of product. To ensure that the documentation is fit-for-purpose and is designed to minimise error