Position: Mid-Senior level

Job type: Full-time

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Job content

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 Senior Quality Assurance 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.

We are growing and we are growing fast. 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
  • Delivery of core expertise to GMP Quality Systems and Compliance to meet business needs and industry regulations
  • Lead improvement projects on core GMP systems to optimise business value for FDBK
  • Lead FDBK as Business Process Owner for key systems such as deviation, change management, management review, GMP training and document control
  • Manage day to day site compliance and maintenance of GMP Quality Systems
  • Lead and manage a team of 20+ people (3-4 direct reports)
  • Be Subject Matter Expert (SME) for GMP Quality Systems in both e-systems and paper systems; being ready to front at Inspection
Qualifications And Experience
  • Relevant scientific degree and relevant industry experience
  • Ability to work autonomously and to hold themselves, their team and their peers accountable
  • Experienced in management of people and of GMP Quality Systems in complex environment of clinical and commercial biologics Dug Substance manufacturing
  • Experienced in managing risk in complex situations where uncertainty of outcome is a factor
Why work with us?

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

In Addition To This, We Offer

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.
  • Competitive salary plus company bonus scheme
  • Up to 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 9th September 2022

Senior QA Manager PS

Senior QA Manager JD

Why Work in Billingham
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Deadline: 16-07-2024

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