Quality Assurance Manager
Do you want to be an important part of a fast-growing international pharmaceutical company with dedicated people and a strong entrepreneurial spirit? Join our small team and become part of our regulatory voice both internally and externally.
You will be a part of the Quality Assurance & Regulatory Affairs team. As our new colleague you will be the overall responsible for the Quality Assurance in Macure Pharma – supporting the future growth & geographic expansion of the company.
Your primary responsibilities will be:
• QMS responsible
• Ensure that documentation, procedures and processes are maintained in compliance in EU GDP legislation
• Quality Agreements with CMO’s and collaboration partners
• Manage & develop change requests and deviations
• Perform training in general quality requirements and/or specific quality processes
• Supporting our Regulatory Affair teams when needed within regulatory lifecycle management of existing MAs in all Northern European countries – SPCs, PILs, preparing and submitting applicable variations
• Review & approval of marketing materials according to current legislation & guidelines by market
• Review & approval of packaging materials
When & Where: Full time or part time according to the candidate’s desires. Office is based in Copenhagen NV.
• You hold a master’s degree within Life Science (M. Sc. Pharmacy or equivalent)
• You have several years’ experience working with Quality Assurance
• You have a profound technical knowledge and commercial understanding
• Positive and open mindset, as well as a drive to influence your colleagues and surroundings
• A willingness to own, lead and deliver projects with a high respect for deadlines
• Ability to work in a small & lean organization, where flexibility is key for success
An interesting and challenging job in a young, growth company with short decision processes. You will have a significant amount of individual responsibility, and the freedom to structure your own day-to-day tasks – all in an international, entrepreneurial atmosphere with an informal and flexible work environment. This is an opportunity for you to grow with the company, and profoundly shape how our QA is managed today, but also in the future. This will all be done in our modern and completely renovated office space with great colleagues. You will be offered an attractive compensation package according to your individual qualifications.
Application: This position was posted in May 2020. There is no application deadline, but we will interview candidates continuously and close the position down once
we have found the right candidate. Therefore, we kindly ask you to submit your application as soon as possible. Please forward to firstname.lastname@example.org.
Further information: In case of any questions, please feel free to reach out to Mads Renlef Henningsen – email@example.com or tel. no. : +45 51 92 99 32
Who is Macure Pharma:
Macure Pharma is a small, international specialty pharma company with focus on mature, niche hospital products. We market and sell a diverse product portfolio across the Northern European countries, and currently we have several products in procedure with relevant authorities.
Our principal focus is late stage pharmaceuticals, and we grow through acquisitions of established products, and through launch of our own niche generics.
We believe in trust and integrity in all aspects of our business. We strive for the highest level of quality and act responsible in all our activities reflecting a high ethical standard. We value honesty and mutual respect and recognize that our success depends on a good internal working environment.
We are currently 15 colleagues at Macure Pharma.
For more details of Macure Pharma, please check our company profile – www.macurepharma.com/company/