Senior/Advanced Project QA Professional

Category:  Quality
Location: 

Koriyama, Fukushima, JP

   

Position Title Senior/Advanced Project QA Professional

Department Quality Assurance

LocationFukushima, Japan

 

Step into a role where quality becomes a driving force for innovation and patient impact. As an Senior/Advanced Project QA Professional, you will shape the standards behind the treatments that transform lives, contributing to a legacy built on curiosity and a relentless pursuit of better solutions. This is your opportunity to join a team that values diverse thinking and empowers you to influence meaningful change in the way we ensure excellence every day. Read on and apply today.

Your new role

As a QA Professional, you will play a key role in ensuring compliance with GxP regulations and maintaining the highest quality standards. Your responsibilities will include:

  • Providing QA oversight and support for projects in Koriyama factory in Japan to ensure timely delivery with the right quality.
  • Participating in project and validation activities to resolve quality-related issues.
  • Performing quality spot checks and approving validation documentation to ensure the highest quality level.
  • Reviewing and approving complex change control requests, SOPs, trend reports, and validation-related documents.
  • Preparing annual product reviews and facilitating validation and other complex internal trainings.
  • Acting as a coach during audits and inspections, and ensuring compliance with regulations and corporate/local SOPs.
  • Providing proactive guidance to departments on quality-related activities and ensuring that current Novo Nordisk procedures and health authority requirements are reflected in quality decisions.

 

 

Your new department
Koriyama factory is a part of the global organisation, and the Quality Assurance team reports directly to the global HQ. This unique structure provides regular opportunities to collaborate with overseas colleagues, such as routine meetings with counterparts and sharing visual inspection data with foreign manufacturers to improve products supplied worldwide. The plant prioritises employee wellbeing and environmental strategy, investing in equipment and facilities to support these goals. The QA team is known for its positive atmosphere, mutual support, and clear performance-based opportunities, regardless of age or tenure. Here, your contributions will be recognised and valued, fostering a culture of appreciation and teamwork.

 

Your skills & qualifications
We are looking for a dedicated and experienced QA professional who can bring the following qualifications to the role:

  • Minimum 5 years’ QA experience, or minimum 7 years’ experience in QC/production or related roles (healthcare/pharmaceutical industry preferred), with a strong quality mindset and solid understanding of QA responsibilities.
  • Expert knowledge of quality management systems and cGMP production processes, with deep understanding of validation in pharmaceutical manufacturing preferred.
  • Ability to make autonomous, high‑level decisions on complex quality issues and to perform effectively with minimal supervision.
  • Strong cross‑functional leadership skills to drive process and team activities and to support others’ ideas and actions.
  • Native-level Japanese and business-level English communication skills, both written and oral.

 

 

Working at Novo Nordisk
Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.

 

What we offer

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

 

More information

You are welcome to contact our Japan Talent Acquisition team at JPHCWG_SAIYO@novonordisk.com if you have questions about the role. Be advised that we might not be able to answer queries about your recruitment status.

 

Deadline
Until the completion of recruitment. Applications will be screened on an ongoing basis.

 

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

 

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We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

 

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.