QC Microbiology Manager

at  Xellia

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• Visit our career page: https://xellia.com/careers
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Our company is committed to attracting, developing, and retaining the greatest talents by offering a motivating and inclusive workplace where talent is truly recognized and rewarded. We are dedicated to providing an inclusive environment for everyone.
Xellia Pharmaceuticals is a specialty pharmaceutical company and a global leader in providing anti-infective treatments and other critical care therapies for serious and often life-threatening conditions. Xellia has an extensive history in developing, manufacturing, and commercializing anti-infective products, including Active Pharmaceutical Ingredients (APIs) as well as Finished Dosage Forms, where the majority are injectable drug products.
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 Pharmaceuticals is wholly owned by Novo Holdings A/S and employs a dedicated team of more than 1,700 people.
Further information about Xellia can be found at: www.xellia.com
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• Manage Quality Control (QC) activities related to regulatory inspections and corporate audits, including audit/inspection readiness, communications, and response handling
• Review and approve API, FDF and IPC-related laboratory investigations, identifying root causes and developing appropriate CAPAs to prevent recurrence
• Adhere to the current EHS / KIR / MEBIR requirements and standards
• Ensure cGMP compliance and provide administrative and professional management of the QC Microbiological laboratories
• Ensure compliance with Hungarian and international pharmacopeias
• Foster continuous improvement and develop solutions to address issues, improve processes and quality metrics
• Drive projects to completion by proposing solutions, gathering feedback from stakeholders, identifying areas which need escalation and sharing lessons learned
• Write and revise SOPs as required for this job function. Circulate for review, incorporate/address reviewer comments appropriately and ensure timely approval
• Escalate issues or potential Quality Events in a timely manner
• Maintain and continuously develop knowledge of global GxP regulations and guidelines, and utilize this expertise to make quality decisions
• Foster Team Leaders, create positive atmosphere and build a good working culture. Manage 3 teams within a department of 20 employees
• Have a holistic overview about the QC activities and their impacts on the related different departments
• Satisfactorily complete all cGMP/GDP, corporate and safety training in conformance with Xellia requirements