Senior QA role within Global Contract Manufacturing

The position

In this position you will be responsible for Quality Assurance of Contract Manufacturing and will be responsible for one or more CMO´s with various products being produced for Novo Nordisk. The QA role includes: The quality responsibility for ensuring that our products are manufactured according to cGMP and our Marketing Authorizations. Numerous encounters daily with both internal and external business partners and a high level of complexity in your daily tasks. You should also contribute to continuous improvements of our processes and strive for simplicity without compromising quality. Handling of documentation from the contract manufacturers is a part of the job and you are also expected to participate in audits performed at the CMO and ensure sufficient follow up on CAPAs. QA support and GMP guidance to our partners and final release of the API and intermediates from CMO`s to the further process in Novo Nordisk. Expected travel is around 15-20 days a year as the Contract Manufacturing Organizations (CMOs) are located outside Denmark primarily Europe and US. If you are looking for a job which can foster the development of your professional and personal competences, this is your opportunity. Qualifications We are looking for an individual who can take ownership, work independently and make decisions that balance quality, expectations and business needs. To be successful in this role, you should have a degree in Pharmacy, Engineering or similar and have at least 4 years of experience in the pharmaceutical industry in manufacturing or quality control, where you have gained a solid and up-to-date knowledge of quality and GMP requirements. We look for a candidate who: Has a natural ability to take lead and work as a team player, and proactively contributes to the team’s tasks and activities. Has the ability to work in an international set-up with external stakeholders with different interests and agendas. Meets own deadlines and knows how to prioritize between different tasks in an ever-changing environment. Has great communication and collaboration skills and speaks and writes Danish and English fluently. About The Department The GCM Drug Substance QA area is responsible for quality assurance and quality support to outsourced production activities worldwide. GCM DS QA is a dynamic area consisting of around 45 competent people with focus on either operations or projects. The department is characterized by a high level of professionalism, flexibility, and cooperation. The primary role of our area is to deliver QA support and set direction for our global CMOs. We focus on good social relations and prioritize to make room for fun at work. We have a great team spirit, and it is important for us that you will be a part of it.At the moment, the workplace is in Søborg, but at the end of we will be relocated to Høje Taastrup. Working at Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.