Global Supply Quality (GSQ) is responsible for the compliance of Xellia’s CMO’s, In-licensing Partners, external suppliers and related contractors (pertaining to CMO’s). Also act as quality partner for Global Supply Chain.
Our goal is to be a professional partner to the CMO’s and Xellia’s internal teams. We strive to become a high-performance group with contribution from all members. We are united and aspiring!
For our Zagreb team we are looking for
Global Supply Quality Specialist (m/f)
Quality
Your responsibilities:
- 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 Vendo 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 GSQ and Quality Leadership Team (QLT)
What do we expect?
- 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
- Minimum 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)
- Demonstrated ability to handle multiple tasks in a fast-paced environment
- Proactive working approach and developed stakeholder management skills
- Thorough proficiency in MS Office
We can offer you:
- Full time global position in an international pharmaceutical company with a "Scandinavian style" - working atmosphere
- Competitive compensation package (including Christmas bonus, holiday bonus, travel allowance and meal allowance)
- Flexible working hours and the possibility to work in a hybrid set-up combining working from home and from the office
- 30 paid vacation days
- 24/7 employee insurance and paid annual medical check-up
Location: Zagreb (Hybrid)
To apply for this position, please send your English CV and application letter via application link.
Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. 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. Together with us, you can help lead the fight against bacterial infections.
Read more about Xellia Pharmaceuticals here.
