Nykode Therapeutics AS

Seeking a Senior QA Specialist for our growing QA department at Nykode Therapeutics.

We are strengthening our QA function and are currently looking for a Senior QA Specialist to join us at Nykode Therapeutics! This is a unique opportunity to become part of our growing and dedicated Nykode team, allowing you to use and further develop knowledge and skills in one of Scandinavia´s leading Biotech companies. 

The position

Our QA team is now looking for an experienced and ambitious Senior QA Specialist to join us in our efforts to further strengthen our QA funtion. In this role you will play a key role in ensuring that documentation, procedures and processes supporting development programs are maintained in compliance with company and industry standards and global regulations. You bring structure and a holistic approach to the role, with a strong emphasis on creating an impact and adding value to Nykode.

The role reports to the Head of QA and is part of a team consisting of dedicated Senior QA specialists and IT experts.

 

Job responsibilities:

• Providing QA support related to batch manufacturing in development projects in close cooperation with Nykode’s CMC team and external CMOs
• Overseeing CMO actvities
• Writing and authorization of SOP’s
• Handling deviations, CAPAs and change control cases 
• Providing relevant input to further professionalise the Nykode Quality Management System (QMS)
• Owning selected quality processes based on experience and interests, e.g. Deviation/CAPA, Change Management process
• Supporting QA team in QA tasks related to GxP regulations

 

Who are we looking for?

When hiring new employees, we are looking for individuals who are inspired by the Nykode technology and our quest to unlock the future of medicine. We are eager to hire people who seek out environments that offer creative challenges and provide growth opportunities. If you feel at home in a highly collaborative, flexible, and courageous company culture, Nykode might be the right place for you. If you additionally are experienced in balancing planning, execution, and internal communication needs with a hands-on attitude, send us your application right away.

 

Qualifications in terms of education and experiences

• Technical background, a MSc degree or equivalent in a relevant life science subject
• Experience from Biotech or Pharmaceutical industry within QA, preferably within ATMPs or Biologics
• Experience from development projects and clinical trials in early stage
• Experience working with CMOs and establishing Quality Agreements
• Excellent understanding of EU and US GMP requirements for IMPs and early phase products
• English proficiency at business level required

 

Desired experiences and skills

• Experience as GxP Auditor is a plus but not a requirement
• Experience across GxP: GLP/GCP/GMP
• Structured approach with a focus on deliveries
• Eagerness to add value for your colleagues at Nykode

 

Applications will be reviewed on a rolling basis with a deadline on 17th of June 2022.

We are looking forward to receiving your application! We do not accept applications by mail. Should you have any further questions regarding the position, please reach out to us: recruitment@nykode.com