Quality Assurance Specialist / Qualified Person

Bayer; Oslo; On-site; NOK 900,000 - 1,200,000; Full time

Job summary

Bayer Norway is seeking a Quality Assurance Specialist / Qualified Person to lead QP certification, product release, and QA oversight across CMOs and partners. The role focuses on radiopharmaceuticals with international supply chains and requires strong GMP expertise.

Candidates with QP qualifications or those eligible for QP in Norway will be considered. Collaboration across departments and cultures is emphasized in this global company.

Qualifications

• QP approval in Norway or qualifications enabling QP approval within a short timeframe.
• Experience in pharmaceutical QA, GMP operations and/or batch release.
• Understanding of EU GMP, Annex 16, sterile products or radiopharmaceuticals.
• Experience with CMO/supplier oversight, deviations, CAPAs and change control.
• Strong communication 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

English & Norwegian

Education

Pharmacist degree (Norway)

Job description

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 [phone] / [e-mail]