Quality Assurance Specialist / Qualified Person

Bayer Norge; Oslo; On-site; NOK 900,000 - 1,100,000; Full time

Job summary

Bayer Norge is seeking a Quality Assurance Specialist / Qualified Person to lead QP certification, product release, and QA oversight for radiopharmaceuticals. The role involves collaboration with CMOs and suppliers, and driving continuous improvement of quality systems in an international setting.

Applicants should have QP eligibility or Norway-based QP approval, strong pharma QA/GMP experience, and fluency in English and Norwegian.

Qualifications

• 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.

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.

Skills

QP approval

GMP operations

QA oversight

CMO oversight

radiopharmaceuticals

Quality systems

Education

Pharmacist degree

QP eligibility

Tools

Quality Management System

Job description

Quality Assurance Specialist / Qualified Person

• Sektor Privat

Responsible for QP certification, product release, QA oversight of CMOs, and optimization of quality systems for radiopharmaceuticals.

• 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
• Strong communication skills in English and Norwegian
• Opportunity to work with next-generation radiopharmaceuticals and precision medicine
• Varied tasks and professional development in an international company

Join Bayer as 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 vision 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: www.bayer.no

Application and Questions Regarding the Position:

The recruitment process is carried out in collaboration with the life sciences search & recruitment firm Borka Consulting AS.

Questions: For more information about this position before submitting your application, please contact: Cecilie Fraas Borka, phone [phone] / email: [e-mail]

At Bayer we always start by listening — because our customers are at the heart of everything we do. Their needs, along with the challenges facing society, inspire us to develop ideas and solutions that truly improve people’s lives. As part of the Bayer team, every employee is committed to understanding and supporting our customers in order to deliver products and innovations that matter — today and in the future.

Bayer Nordic is our regional organization for Northern Europe, with operations in Finland, Denmark, Norway, Sweden, Iceland, and the Baltic countries (Estonia, Latvia, and Lithuania). We are more than 1,400 passionate employees dedicated to making a difference.

In the Nordic region we host two global R&D and production sites, located in Finland and Norway. Our Turku-based facility is one of Bayer’s global pharmaceutical production hubs, manufacturing medicines for over 130 countries worldwide. In recent years, Bayer has increased its investments, research activities, and partnerships across the Nordic region, strengthening our role as one of the most significant life science companies in the area.

Why Bayer?

Because we are pioneers in the fields of human and plant health. Because we invent solutions that contribute to a sustainable future for our planet. And because a career at Bayer allows you to put your passion into practice and make a real impact.

Workplace & Culture

At Bayer we are visionaries, driven to solve the world’s toughest challenges and striving for a future where Health for all, Hunger for none is no longer a dream, but a real possibility. We pursue this mission with energy, curiosity, and dedication — always learning from the unique perspectives of those around us, expanding our thinking, growing our capabilities, and redefining what is possible.

There are many reasons to join us. If you are eager to build a varied and meaningful career in a community of brilliant and diverse minds, and want to make a real difference, there is only one choice: Bayer.