Quality Assurance Manager

Fujifilm Diosynth Biotechnologies is investing £400M to introduce a new, state-of-the-art biomanufacturing facility. This biomanufacturing facility will provide additional Cell Culture and Viral Gene Therapy cGMP manufacturing capacity to the existing Billingham, UK campus and is expected to become operational in 2025.

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.

• Represent all of Quality at the program level.
• Own S&OP business milestones for projects, provide timely identification and escalation of at risk milestones using business tools (eg: Gantt charts, trackers, risk assessments, etc) and drive remediation or mitigation.
• Drive the programme within Quality from kick off through to disposition.
• Guide and/or author the generation of key Quality documentation to support manufacture of Product (eg: cell bank, drug substance, etc).
• Ensure that all GMP documentation is in place, accurate and ready on time for GMP manufacture and linked activities.
• Escalating concerns early to enable timely changes.
• Review and approve quality documentation such as Product specification, customer’s regulatory submissions, qualification and validation protocols and reports.
• Ensure programme reviews take place follow GMP manufactures, identify any learning is captured, communicated and actions put in place to make identified improvements across Quality/Manufacturing.
• Ensure change in scope of a manufacturing programme is raised to the Programme Manager and only progressed once approved (i.e. via a programme amendment order).
• Overcome technical problems by scientific understanding, options assessment and application of novel and innovative solutions.

• Science Degree or equivalent
• A minimum of 5 years’ experience in a Quality (QA/QC) role. 
• Greater than 2 years’ experience in a regulatory environment (GMP/GLP). 
• Good understanding of analytical techniques, such as: HPLC, SDS-PAGE 

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 30th August 2024

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Why Work in Billingham