Quality Assurance Specialist / Qualified Person
Bayer Norway is at the forefront of developing next generation, targeted radiopharmaceuticals, shaping the future of precision medicine.
Through innovation and deep scientific expertise, we are advancing breakthrough solutions that address unmet medical needs. Alongside our leadership in radiopharmaceuticals and oncology, we maintain a strong and impactful presence across key therapeutic areas including cardiovascular health, ophthalmology, and women’s health – driven by our purpose to transform lives through science - and truly living our vison Health for all, hunger for none.
We are looking for a Quality Assurance Specialist / Qualified Person
As a Quality Assurance Specialist / Qualified Person at Bayer AS, you will have important responsibilities within the company’s quality assurance and routine operations. The position is part of the QA/QP group, and the main tasks include release of products manufactured by our contract manufacturers, development and follow-up of quality tasks related to production and manufacturers, participation in projects as a QA specialist for new products under development, and further development and optimization of our quality systems. Our contract manufacturers and collaboration partners are located both nationally and internationally. The work involves extensive collaboration across departments and with different partners and cultures, and we emphasize ensuring good and effective communication and sound assessments related to product quality. The position reports to the Head of Quality.
We are looking for candidates with experience as Qualified Person (QP), but pharmacists with experience and qualifications which enables QP approval within short time might also be evaluated. Experience in the development of digital quality management solutions and with project management will be valued.
Key responsibilities
• Perform QP certification, disposition and release of commercial and development products, including IMPs.
• Provide QA oversight of CMOs, suppliers and external partners, including batch documentation, deviations, CAPAs, changes and complaints.
• Support efficient release processes for radiopharmaceutical products with complex international supply chains.
• Act as QA representative in product, supply, CMO and development teams.
• Review and approve relevant quality, validation, regulatory and technical documentation.
• Contribute to audits, inspection readiness and continuous improvement of quality systems.
Profile and Experience
• QP approval in Norway, or qualifications enabling QP approval within a short timeframe.
• Strong experience from pharmaceutical QA, GMP operations and/or batch release.
• Good understanding of EU GMP, preferably including Annex 16, sterile products or radiopharmaceuticals.
• Experience with CMO/supplier oversight, QAAs, deviations, CAPAs and change control.
• Structured, independent and able to make sound quality decisions under time pressure.
• Strong communication skills in English and Norwegian.
As a colleague you have a structured and systematic mindset and like to take responsibility in a hectic working environment. You are solution oriented and have good communication skills, both verbally and in writing. You have a collaboration -oriented mindset but are also comfortable working independently. Bayer values are central in our daily work, with leadership, integrity, efficiency and flexibility key to how we work.
We offer an exciting position in an international company. Together with professional and engaged colleagues you will strengthen Bayer’s work and position in the Norwegian market. The position offers challenges enabling development and an interesting and varied working day.
The position will be located at Bayer AS main offices at Lysaker in Oslo, Norway.
For more information see: https://www.bayer.no
Contact details
The recruitment process is carried out in collaboration with the consulting company Borka Consulting AS. If you would like to find out more about this position before submitting your application, please do not hesitate to contact Cecilie Fraas Borka, phone +47 928 55 352 / cecilie@borka.no
How to apply
If you meet the requirements of this opportunity and want to impact our mission Science for a Better Life, we encourage you to apply now, at the latest DATE
Please apply with an updated CV and Cover letter in English. We will review the applications on continuous basis. We reserve the right to close the advert earlier.
- Team
- Pharma
- Locations
- Bayer Norway
- Last application date
- 29 September, 2026
BECOME A PART OF BAYER
Bayer Norway
Workplace & Culture
At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where, 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We’re doing it with energy, curiosity, and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.
About Bayer Nordic
At Bayer we always start by listening – because our customers are at the heart of everything we do. The needs of our customers and the challenges facing society inspire us to develop ideas that improve people’s lives. As part of the Bayer team, each of us needs to thoroughly understand and support our customers in order to deliver products and solutions that matter – now and in the future.
You find us in Finland, Denmark, Norway, Sweden, Iceland and the Baltic countries, i.e. Estonia, Latvia and Lithuania. We are more than 1400 people who are passionate to make a difference.
In the region we have two global R&D and production sites, in Finland and Norway. The Turku-based production facility is one of the Group's global pharmaceutical production facilities, where medicines are manufactured for more than 130 countries. Over the last years Bayer has increased its investments, research activities and partnerships in the Nordics, and we are proud of being one of the most significant Life Science companies in the region.
Why Bayer? Because we’re a pioneer in the fields of human and plant health. Because we invent the solutions that will create a sustainable future for our planet. Because a career with Bayer means you can put your passion into practice and make an impact.