QA Project Specialist LCMO

The position

In this position you will be the QA representative in project transfers from Novo Nordisk to CMOs. You will participate in various projects within Drug Products and Finished Products, working with both internal and external business partners and with a high level of complexity and independent decision making in your daily tasks. Main responsibilities include: Quality responsibility for the technical transfer to the CMOs in market and capacity expansion projects and be responsible for setting the quality and compliance direction Taking lead in ensuring the CMO Quality Management System (QMS) is compliant to fulfil relevant GMP requirements You will promote good collaboration with the CMO as well as build the Quality mind-set and Compliance culture at the CMO, including activities such as to train the local CMO QA organization to maintain and improve compliant operation and to act as both coach and mentor at the CMO’s Negotiation and implementation of quality agreements, approving process validation strategy and related documents Setting up the QA processes for commercial manufacturing. Participating in qualification audits performed at the CMO and ensure sufficient follow up on CAPAs Moreover, you will manage quality issues during the technical transfer such as: Process validation documentation, deviations, out of specifications, change controls, action plan and follow up, evaluate production documentation. Expected travel is around 25 days a year as the CMOs are located outside Denmark. We are currently collaboration with CMO’s in Saudi Arabia, India, Bangladesh and South Africa and we are exploring opportunities in other countries. You will have great professional and personal development opportunities in a well-functioning department. We can offer you a working environment with a high level of team spirit as well as highly skilled, ambitious, and engaged colleagues. Qualifications To succeed in this role, you: hold an academic degree as Pharmacist, Engineer or similar have a minimum of 5 years' experience from the pharmaceutical industry either from production or QA have a solid and up-to-date knowledge of quality and GMP requirements and have the ability to take decisions on quality representing Novo Nordisk are proficient in English and knowledge of other languages will be an advantage It is an advantage if you have extensive knowledge within aseptic Drug Products. On a personal level, you have a natural ability to take lead and work as a team player, proactively contributing to the team’s tasks and activities. You have the ability to work in an international set-up with external stakeholders with different interests and agendas, using your great communication and collaboration skills. We would enjoy welcoming a straightforward person with a good sense of humor to our department. Finally, you meet own deadlines and know how to prioritize between different tasks in an everchanging environment. About the department Global Contract Manufacturing (GCM) QA is responsible for quality assurance and quality support to outsourced production activities worldwide. In LMCO QA one of the primary roles is to deliver QA support and set direction for CMO’s in countries where local presence is required to maintain market access. GCM QA is a dynamic department consisting of 70 competent people divided into 8 teams with focus on either operations or projects. You will be a strong player in the project team. The department is characterized by a high level of professionalism, flexibility, and cooperation. The primary role of our department is to deliver QA support and set direction for our global CMOs. At the moment, the workplace is in Søborg, but at the end of we will be relocated to Høje Taastrup. We focus on good social relations and prioritize to make room for fun at work. 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.