Advanced QA Professional, Koriyama Factory

Job description

Location

Koriyama, Fukushima, Japan

Job category

Quality

Job Title: Advanced QA Professional

Department: Quality Assurance, Koriyama Factory, Global Manufacturing & Supply

Location: Koriyama, Fukushima, Japan

Your impact begins here

As Advanced QA Professional, you will be the quality voice in projects at our Koriyama Factory in Japan. Joining a project-focused QA team, you will provide QA oversight of project and validation activities so they are delivered on time and at the right quality. By reviewing critical documentation, solving quality issues alongside project teams and keeping decisions aligned with GMP and health authority requirements, you help make sure what we produce in Koriyama meets the standards people rely on.

What you’ll bring

You care about quality and you’re confident making clear, well-reasoned decisions in a GMP environment. To succeed in this role, you will bring:

• Fluent English, spoken and written
• Japanese at JLPT N2 level or above, so you can work comfortably with colleagues across the site.
• A strong quality mindset and an understanding of what manufacturing regulatory compliance means in daily manufacturing work.
• The ability to work accurately and to deadline, both independently and as part of a team, while prioritising a changing workload.
• Strong relationship-building skills and the ability to explain detailed quality information clearly to colleagues in other functions.
• A proactive, adaptable approach and the willingness to mentor colleagues and recognise their contributions.

Useful, but not essential:

• A scientific education, for example as a pharmacist, engineer, biologist or equivalent.
• Around 5 years of experience in production, QC and/or QA, ideally in the pharmaceutical industry.
• Strong knowledge of cGMP production processes, quality management systems and validation in pharmaceutical manufacturing.

What you’ll do

Projects move fast, and quality has to keep pace. You will be part of project and validation work from the start, helping teams solve quality issues and deliver with confidence.

• Provide QA oversight of projects at the Koriyama Factory, helping them deliver on time and at the right quality.
• Take part in project and validation activities, solving quality-related issues together with project teams.
• Perform quality spot checks during validation projects, and review and approve validation documents, complex change control requests and SOPs.
• Make sure quality-related decisions reflect current Novo Nordisk procedures and health authority requirements, and that both you and the site stay compliant.
• Take part in audits and inspections, and coach colleagues through them.
• Give departments proactive quality guidance and facilitate validation and other internal training when needed.

Who you’ll work with

You will join the project-focused QA team within Quality Assurance at the Koriyama Factory, part of Global Manufacturing & Supply. In Global Manufacturing & Supply, colleagues work across the value chain to scale molecules, processes, devices and products for the people who need them.

Day to day, you will work closely with colleagues in other departments across the Koriyama Factory, as well as FPM Quality and LM Quality. You will also work with Novo Nordisk Pharma Ltd. (NNPL), our organisation in Japan. Your scope is Japan, and your role is to bring clarity to quality questions so projects keep moving without compromising on standards.

You will report to Project Manager, QA team.

What you can expect here

You will be trusted to take ownership of quality decisions in your area, with support from your manager and senior colleagues when you need it. Your expertise will shape how projects move forward, and your voice will count in cross-functional discussions.

You will build new skills through hands-on project and validation work, audits and inspections, and by coaching others. You will also have the chance to help improve the quality procedures, processes and systems you work with every day. It’s a team that values honest feedback and appreciation, and that holds itself to high standards on quality and patient safety.

Start now

Your impact begins today. If you are ready to bring QA expertise and clear judgement to projects at our Koriyama Factory, apply for the Advanced QA Professional role.