Quality Assurance Manager - Life Science

Quality Assurance Manager to expanding Life Science company

Are you eager to develop yourself in a fast-paced environment? Do you thrive on challenges and want to be a critical player in our ongoing growth journey? Look no further - the operations team at Niconovum AB is looking for a new QA Manager.

The Company

Niconovum AB is a Sweden-based pharmaceutical company that markets innovative nicotine replacement therapy (NRT) products under the Zonnic brand. Our products are sold in Sweden, Norway, Finland and Iceland, and the Zonnic brand is #3 in terms of market share in each market – but gaining share every quarter. The company is experiencing very strong growth and is now in the process of setting up a new manufacturing facility in Ystad, where this role will be based.

The Role

As the Quality Assurance Manager in the Niconovum production organization, you will be reporting directly to the Plant Manager, with an indirect reporting relationship to the Head of Quality for Niconovum based in the Corporate Office in Malmö (Hyllie). You will be part of a group of up to 20 people consisting of technical and operational personnel.

In 2021 and 2022 the focus of your work will be project based to get the new pharmaceutical factory built and approved by the Swedish Medical Products agency. As QA Manager, you will be responsible for overseeing and maintaining the quality and compliance work at the site. You must ensure that the new factory meets the GMP-related requirements and documentation for all operations. You will also routinely interact with internal and external stakeholders, including Niconovum´s Qualified Person to uphold the GMP license.

Main responsibilities include:

•Reviewing and controlling all batch documentation

• Releasing internal processes and intermediates

• Identifying, documenting and following-up deviations and change controls within the quality system

• Investigating product complaints

• Writing and approving SOPs

• Writing and approving validation and qualification documents

• Giving GMP support and following up on compliance

• Developing and executing GMP training

• GMP inspections and audits

• Leading the quality work within the operation at the site, performing risk analysis and maintaining the CAPA system

• Assisting the Head of Quality in developing strategic plans and business cases, as needed

Background sought:

• Bachelor´s degree or Master of Science in a relevant field

• Quality related experience within life science

• Demonstrated experience resolving compliance and regulatory issues, particularly GMP

• Lean, Six Sigma or similar competence or experience

 

We think you are someone who appreciates and initiates structure and routines. And most important of all - quality is always your guiding star.

Niconovum is a small, fast and flexible organization so you must be able to work both on a strategic and operational level. You will interact and communicate on all levels throughout the Niconovum organization. For this, you will need excellent Swedish and English language skills both verbally and in writing. As a person, you must be organized, diligent, and conscientious, with the professional maturity to work independently, but seek input from colleagues when necessary. You are analytical, thorough, detail oriented and with utmost integrity.

And now?

This process is in collaboration with Badenoch + Clark. For any questions regarding the position, please reach out to Senior Consultant Matilda Rodey at matilda.rodey@badenochandclark.se.We look forward to receiving your application as soon as possible, at www.badenochandclark.se or using link below. Selection will be ongoing – so contact us today!