Qualified Person (for Clinical Assembly Production)

Do you want to use your strong quality mindset and great interpersonal skills to ensure products of the highest quality to serve our patients? Are you eager to play an important role in ensuring the quality and safety of products for [xxxxx] clinical trials?
If so, we have an exciting possibility waiting for you as QP Specialist in Device Manufacturing Development QA (DMD QA). Apply now and start a life-changing career! The Position In this role, you will work as a QP and Compliance Specialist, covering clinical assembly batches and you will be part of a team of 11 engaged and highly skilled QA colleagues. The area we support is the assembly and release of products for [xxxxx] clinical trials run worldwide. We play a crucial role in delivering products at the right time in the right quality to ensure patients enrolled in clinical trials can rely on our company. Your main responsibilities as a QP and Compliance Specialist will be to:

Act as a QP to release drug and combination products from our assembly facility for clinical trials

Act as a QP and as a role model setting direction in the batch status assignment and release process for a dedicated team of QP delegates

Act as a Compliance Specialist and as a role model setting direction in the compliance processes (e.g., QMS) for dedicated QA colleagues in the department

Support the clinical assembly facility and processes with validation tasks

Depending on your level of experience and ability to act across different subject matters, you will contribute to improvement projects both internally with our stakeholders and across the [xxxxx] Quality organisation. Qualifications The most important asset that you can bring to succeed in this job is a well-developed understanding of quality and a natural urge to handle quality issues at the right level, make decisions and follow-up on quality related problems. To succeed in this role, you:

Hold a master’s degree in pharmacy, medicine, veterinary science, pharmaceutical chemistry and technology, chemistry, or biology. Please note that your education must support the requirements to a “Qualified Person” from the Danish Medicines Agency (Lægemiddelstyrelsen), therefore while applying we ask you to upload your diploma.

Have 5 or more years of experience within a GMP regulated manufacturer, preferably in quality assurance

Have experience with batch release/status assignment

Are fluent in English

Prior experience with medical devices and combination products would be an advantage.
On a personal level, you are ambitious and ready to take responsibility for building strong competencies within our team and fostering trustful relationships across the organisation. You can use your excellent cooperation skills when you manage your stakeholders to ensure solutions that will meet both requirements and stakeholder’s interests. You want to make a difference and are eager to learn. Finally, you are well-organised and have a flexible, but firm approach when making decisions. About the Department At DMD QA, we are a team of 30+ highly qualified professionals based at our Hillerød site, with diverse backgrounds and interests. We are responsible for ensuring the quality and compliance of all processes in DMD, including product development and life cycle management, design control, testing, manufacturing development, and manufacturing processes. We take pride in our work and are constantly seeking to improve our competencies and processes through a focus on simplicity and collaboration. By joining our team, you will have the chance to make a real difference in the lives of patients through the development and life cycle management of crucial medical devices. Working at [xxxxx] At [xxxxx], 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.
Contact For further information, please contact Manager, Nikolaj Jespersen at +[xxxxx]
Deadline 19 June 2024 Please note that applications will be reviewed continuously, and interviews will be planned as soon as suitable candidates have been identified. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.