Quality Specialist in Quality Support
Location: Gdansk 80-309, Poland, Poland
Contract type: Permanent
Job ID: 2448
Quality Specialist within External Manufacturing in Quality Support. Utilize your natural science skills in a job with great opportunities. Are you looking for a challenging job that involves a broad range of relations and stakeholders, as well as the opportunity to bring all your skills into play and have a steep learning curve? This is it. No two days will be alike when you turn challenges into solutions together with your highly skilled and dedicated colleagues in a very well-functioning team.
LEO Pharma has embarked on an ambitious journey to become the preferred dermatology care partner, improving people’s lives around the world – and that is why we need you. As a Quality Specialist in Quality Support, you will have the opportunity to shape the future and help people with skin diseases live more fulfilling lives by advancing the standard of care.
Your role
As a Quality Specialist in the Quality Support team, your most prominent objective is to provide guidance and support, ensuring that the handling of Deviations and Change Controls related to our external Contract Manufacturers (CMOs) is carried out in accordance with the requirements of GxP and our Quality Management System. It is important to note that the job is highly administrative and not associated with LEO Pharma’s own production on-site in Ballerup.
You will
• Be responsible of driving Change Controls and Deviations related to our CMOs – in close cooperation with cross functional areas and our external Contract Manufacturers
• Provide Quality support to the External Manufacturing Leads and handle all kinds of GMP relevant challenges
• Participate in identifying and implementing corrective and preventive actions
• Participate in our on-going optimizations of processes, methods and tools
You can look forward to collaborating with multiple external partners and colleagues across the global organization, especially your colleagues in the Quality area.
Natural science degree and experience with Change Controls and Deviations
• You have a natural science education, such as a Pharmacist, Engineer, Pharmacologist, or similar.
In addition to this:
• You must have the necessary quality mindset and GMP knowledge and could have 2-3 years of experience in similar positions.
• You should be structured and able to keep an overview of many tasks/cases under your responsibility – being able to park the ones with no immediate actions and work with the few actionable task on a daily base.
• You must be comfortable asking questions to gain the necessary understanding of, for example, a certain process.
• You like to create results via constructive collaboration with due respect to cultural and professional differences.
• As part of a team with great responsibility, you must also be responsible for your own tasks – if you can’t solve a problem yourself, you can find a colleague who can.
• Being part of an agile organization also calls for your ability to keep up the good spirit when things do not turn out as foreseen.
As an individual, you are open-minded, self-driven, positive, and a team player. Open for changes and a daily life filled with unforeseen activities. You are curious and thrive in a variable and dynamic environment, where collaboration and communication with many different stakeholders and Quality colleagues are needed to succeed in your role.
Your new team
The Quality Support DK team consists of 12 dedicated and experienced employees and is part of Denmark and ExMAN Quality. The team handles a broad range of quality records related to external Contract Manufacturers (CMOs), and quality activities to ensure ongoing daily operation and compliance with regulations and guidelines and acts as a quality sparring partner for our stakeholders at the Danish manufacturing sites.
We work flexibly, meaning that you will have the possibility to work remotely and adjust your working hours as working tasks permit.
We look forward to receiving your application.
Contact and application
If you have questions, please do not hesitate to contact Helene Lyngby Nielsen, Head of Quality Support DK, at +45 31203825.
You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has piqued your interest.
Beyond the skin
Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact. Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet.
At LEO Pharma, we believe in the power of individuals to drive change. Our flat organizational structure empowers you to make a visible impact and offers versatile roles for professional growth. We value diversity and welcome applications from all qualified candidates, recognizing that our different perspectives, backgrounds, and attitudes enable us to make the best decisions. Join our passionate team at LEO Pharma and be yourself as we work together to make a difference.
For certain positions, LEO Pharma might complete a background check conducted by a third party.
Join us on our journey Beyond the Skin. Apply today!