Are you passionate about ensuring compliance? Looking forward to put your expertise within small molecules, stability, and lifecycle management into play? Do you thrive in navigating complex stakeholder landscapes and motivating teams to deliver great results?
If so, we have an exciting opportunity for you, read more below and apply!
The position
As a Senior QA Professional in our Emerging Technologies QA team for Manufacturing Science and Technologies (MSAT), you will play a critical role in ensuring the quality and compliance of our novel manufacturing methods, products, and technologies. Your responsibilities will include reviewing and approving documents related to stability, process validations, and product specifications for oral drug products and active pharmaceutical ingredient products.
In addition to these core responsibilities, you will also:
be responsible for leading complex cases with a high level of attention
drive innovation projects with stakeholders both locally and internationally
help set the quality direction and ensure alignment across the organization
Your focus will be on influencing and setting the right level of compliance, optimizing processes through a LEAN mindset, and establishing new processes that support our business objectives.
This position will be situated in Taastrup from September 2024, and the office presence is expected at minimum three days weekly.
Qualifications
The ideal candidate has 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:
have a master’s degree in Biology, Engineering, Pharmacy, Chemistry or similar
have solid experience with quality assurance and/or production
have gained said experience in either the pharmaceutical or medical devices industry
are capable of taking tough quality decisions
are fully proficient in English
It will be seen as an advantage if you have worked with small molecules, Active Pharmaceutical Ingredients, solid dosage forms (tablets) and have experience in handling contract manufacturing organizations.
On a personal level, you are a self-motivated and independent person with a high level of responsibility and initiative who can prioritize your various tasks. You enjoy working in a dynamic environment, where teamwork is essential, and you like collaborating with many different stakeholders – internally and externally.
About The Department
Emerging Technologies QA is a new area within Novo Nordisk where the oral portfolio plays a significant role, currently employing. approximately 100 employees but still growing. We work with assuring quality and compliance of the facilities, the equipment, QC lab, manufacturing development as well the release of tablets and future emerging technologies products for the market. We are proud to work in a fast-growing part of Novo Nordisk.
You will become part of a great QA department (Emerging Technologies QA New Entry & Support), with many interfaces around the organization. The department consists of around 30 people divided into four teams, and this position is in the QA for Manufacturing Development team. The team consists of 9 highly knowledgeable and skilled people, covering the diverse area of Manufacturing Development.
In the department, we take great pride in our work and value challenges as opportunities. We have a vibrant and positive working environment, good values and exchange of knowledge and experience. We all work towards continuously improving our competences, as well as making work processes more efficient and effective.
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