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Quality
We are looking for an experienced Senior Quality System Specialist to join our Global Quality Systems and Training team (GQST). You will step into a very important role, as you will be a global business process owner for some of our key quality processes. The position will be based in Copenhagen; however, some travel should be expected.
You will become part of an experienced team
The Global Quality Systems, Audits and Compliance (GQSAC) department consists of 12 highly specialized individuals divided into four teams; one of which is the Global Quality Systems and Training (GQST). We are a global team with colleagues in Budapest, Copenhagen, Oslo, and Cleveland.
GQST has a central role in establishing an effective and efficient Quality Management System (QMS), which sets the direction and guides all Xellians to work in compliance with the regulations that govern our industry. As a global team, we ensure that the quality processes, when updated, will continue to provide value and work as intended across all sites and countries. As such, GQST is considered a key business partner across functions.
What will you do?
You will be working together with a very dedicated global team, but you will be the team’s ambassador at the site in Copenhagen. You will be the key point of contact for a lot of local stakeholders, and you will be responsible for taking GQST initiatives to a new level at the site in Copenhagen.
As our new Quality System Specialist, you will be a global business process owner for some of our processes, including but not limited to: data integrity, document management system, deviation, risk management, and CAPAs.
In this role, you will be expected to:
- deliver process improvement activities, update procedures, and oversee the implementation
- design, create, and plan delivery of training across multiple sites
- identify, define, and implement appropriate key performance indicators
- collect the data needed to measure and manage process performance
- establish and/or lead a process or sub-process core team with guidance
- understand how relevant IT systems support/enable the business process
- partner with our global IT function and advise on GxP compliance
Quality is in our DNA
Quality is embedded in every aspect of our business, and the way we support our internal and external customers. You will become a part of team that share the passion for Quality Management Systems, Process Management and its IT Systems. As process owner, you will have a network of Specialists across our sites globally with whom you will collaborate on continuous improvement initiatives. For processes supported by IT systems, you will also work in close collaboration with the system developers located in various locations around the world.
What experience do you need?
You must have a relevant academic degree with a minimum of 5-6 years of experience. Also, you must be fluent in English, both in terms of verbal and written communication. You should have a good understanding of pharmaceutical quality management processes with relevant work experience.
Knowledge of Good Automated Manufacturing Practices (GAMP) and computer system validation is an advantage.
Key Competencies
In order to be successful in this role, you
- must have a pragmatic mindset and effective communication skills towards a diverse range of stakeholders to promote quality mindset and facilitate change
- must be an open-minded person who considers multiple points of view
- should enjoy challenges and the rewards of being of service to others
- must be able to build strong relationships with our business partners
What will we offer you?
At Xellia, we focus on having a great working environment, job satisfaction, and good conditions. You get a challenging job in an international and dynamic company, where you can look forward to having a close collaboration with highly qualified colleagues and a wide range of contacts. You will get a varied and independent job with great responsibility and a good working climate with room to have a fun working day. We also offer a competitive salary package that matches your qualifications.
Contact and apply
Please submit your CV and cover letter as soon as possible and no later than October 18. If you have any questions regarding the position, you are welcome to contact GQST Manager Balázs Brunner on phone +36 30 3417145.
Xellia Pharmaceuticals is a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections. Headquartered in Copenhagen, Denmark, Xellia has a global footprint with R&D, manufacturing and commercial operations across Europe, Asia, the Middle East and North America. Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of over 1,800 people.
With over 115 years of experience, Xellia is a world-leading trusted supplier of several important established anti-infective drugs, comprising active pharmaceutical ingredients as well as injectable products. Continuing the Company’s evolution, Xellia is generating an innovative pipeline of value-added anti-infective medicines intended to enhance patient care, providing convenience and ease of use for healthcare professionals.
Together you can help us lead the fight against infections.
Further information about Xellia can be found at: www.xellia.com
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Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 31.5.2022, men kan have været deaktiveret og genaktiveret igen.
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