Are you our new GxP Audit & QA Supplier Manager?

Do you want to contribute to unlocking the future of medicine? And do you want to help set the direction in our QA team? In our team we have high ambitions and are looking for a GxP Audit & QA Supplier Manager

You will take up a new and important role in a well-established team of specialists, where you will work both strategically and operational and be provided with the opportunity to further develop the GxP Audit and Supplier Management processes at Nykode. The goal is to ensure quality oversight of outsourced activities covering supply chains and service providers as well as creating and operating a risk-based internal audit program to cover internal GxP activities. Furthermore, you will be part of cross-functional initiatives to improve overall supplier/vendor management across Nykode.

Job Title: the title is given according to experience

Application deadline: Applications will be reviewed on a rolling basis

Location: Lyngby, Denmark or Oslo, Norway.

As our new Audit & Supplier Manager you will participate in cross-functional QA initiatives and projects and be responsible for developing a risk-based GxP Audit Programme covering both internal and external audits in collaboration with relevant stakeholders as well as manage the GxP Audit process, furthermore you will be responsible for the QA related activities for supplier/vendor management. More specifically you will:

• Perform audits both internal and external as Lead Auditor as well as managing external audits service providers, where audits are outsourced
• Revise SOPs and associated working instructions, templates, and forms as relevant. Define and monitor audit KPIs/metrics and give input to vendor assessments and Quality Management Review
• Ensure audits are resourced, conducted, and reported in accordance with applicable SOPs
• Provide learnings and insight from internal and external audits to the relevant organizational teams and escalate compliance issues and risks to Senior Management
• Ensuring timely closure of audits and appropriate CAPA plan review and approval in collaboration with auditors
• Creating GxP Annual Audit Plan and reviewing audit deliverables such as individual audit agenda/plans and draft/final audit reports
• Support preparation, hosting, and follow-up activities in relation to Regulatory Authority Inspections of Nykode as well as partner audits of Nykode
• Maintain list of approved suppliers and vendors performing activities regulated by GxP
• Drive supplier/vendor assessments process in collaboration with internal functions.

Education and experience

To succeed in this role, we believe you must have solid experience working with GxP audits in Pharma/Biotech as well as a good understanding of drug development and GxP requirements. Previous experience developing risk-based audit programs and managing audit teams of both internal and external auditors is desirable. Good interpersonal skills and the ability to build relationships with various stakeholders are essential attributes. You will be working in close collaboration with colleagues from all functions within the organization as well as external Audit service providers and internal/external auditees. We imagine that you have:

• A university degree in Life Sciences or related discipline
• Approx 5+ years experience from the biotech/pharmaceutical industry with GxP responsibilities
• Formal training as auditor and experience conducting GxP audits preferably as either GMP or GCP auditor
• Excellent knowhow of the EU/US/RoW regulations in one or more GxP areas
• Excellent verbal and written communication skills
• Desirable is experience working as Inspector, and/or managing auditor teams.

The position is based in either Lyngby or Oslo and you will report to the Head of QA. Since you will be working close to your Norwegian colleagues you must consider some travelling time occasionally. Most often, you will be able to plan this yourself.

Who are we looking for?

When hiring new employees, we look for the people who are inspired by the Nykode technology and our quest to unlock the future of medicine. We embrace new ways of thinking and doing. When growing and building our teams, we look for the people inspired by our mission and those seeking to join a collaborative and value-based company culture. An eagerness to learn and continuously develop is a core characteristic of our highly skilled and competent individuals. Life at Nykode is an opportunity to take part in the journey to push the boundaries of human advancement. Our work is meaningful, and we care. We care about the patients, and we care about each other.

Nykode as a company

You will be part of a growing company where many different nationalities and educational backgrounds try to unlock the future of medicine every day. 

We are a leading technology platform that unlocks unlimited possibilities for the future of medicine through our intelligent modular design and tailored hyper targeting. 

At present, Nykode is in two locations - in Oslo, Norway and in Lyngby, Denmark. We attach great importance to collaboration and knowledge sharing through the establishment of science day, Company days, workshops and partnerships.  

As an employee of Nykode, you will meet diversity, lots of skilled and dedicated employees, flexibility, and many opportunities to develop your professional skills. If you want to know more about Nykode, the employees and partners, take a closer look at our website www.nykode.com

The application process

We see diversity as a strength and encourage all interested candidates regardless of personal background to apply. Applications will be reviewed on a rolling basis. Apply via the link and please note that we do not accept applications by email. 

Should you have any further questions regarding the position, do not hesitate to reach out to: Peter Fatum at Pfatum@nykode.com

We are looking forward to receiving your application!