Xellia Pharmaceuticals is a leading developer, manufacturer and supplier of life-saving anti-infectives. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients’ quality of life. We are a specialty pharmaceutical company focused on fermented antibiotics and injectable finished products. Headquartered in Copenhagen, Denmark, and owned by Novo A/S, we are more than 1500 employees globally. From state-of-the-art manufacturing sites in the U.S, China, Denmark and Hungary to R&D sites in Norway and Croatia; Xellia Pharmaceuticals excels within innovative product development to deliver high quality products.
For our Zagreb team we are looking for
Global Procurement & External Supply Quality Specialist (m/f)
As member of GPESQ team
- Ensure Xellia’s Contract Manufacturing business is always inspection ready
- Set-up and maintain policies and procedures regarding Management of Contract Manufacturers and External Suppliers
- Responsible for Supplier Quality Management
- Monitor performance of material suppliers and third parties by providing on site quality oversight
- Drafting and coordination of various Quality agreements with third parties, suppliers, and contractors.
- Review and approval of MPCR / executed BPCR, Analytical data, QMS notifications
- Coordination, review and investigations for complaints received for contract manufactured product.
- Review and approval of various quality notifications, investigations, batch production and control records and validation documents
- Release of contract manufactured products for US / EU / RoW and support QP during product release for EU.
- Responsible for Good Distribution Practice tasks related to third parties.
- Review of analytical data, chromatograms, ongoing stability program.
- Participate in Compliance Audits for third parties
- Co-operate with Xellia internal stakeholders in relation to third party projects, technology transfer, launch etc.
- Ensure that relevant information and documentation is shared with internal stakeholders and Xellia customers
- Escalate third party compliance issues with sizeable impact to Xellia business and provide insights on how to close the gap to the Head of GPESQ and Quality Leadership Team (QLT)
- graduate degree in Pharmacy, Biotechnology, from Faculty of Science or related studies
- Strong GMP and pharmaceutical knowledge and experience – be able to identify compliance gaps in Xellia sites and contractors and provide solutions to close the gaps
- min. 3 - 5 years of experience in similar position in pharmaceutical industry and has worked in different areas of Quality, preferably supplier quality management
- fluency in English language (spoken and written)
- thorough proficiency in MS Office
- demonstrated ability to handle multiple tasks in a fast-paced environment
- proactive working approach and developed stakeholder management skills
- excellent interpersonal and communication skills
- experience in similar position
- experience in pharmaceutical business
- competitive compensation package
- challenging job in a fast-growing international pharmaceutical company
- "Scandinavian style" - working atmosphere
In this role you will be given the freedom to handle a wide variety of tasks in interaction with a large part of the organization & external partners. But also in more general terms, Xellia offers an exciting opportunity to contribute and grow. We are large enough to drive change, yet small enough to depend on each single individual in our organization. We have a flat structure, a friendly culture, and a strong will to win.
To apply for this position, please send your English CV and application letter only via the application link no later than August 5th 2020.
Please note that only candidates who match the required criteria will be contacted for further selection process.