Mikrobiológia Menedzser

QC Microbiology ManagerAbout the JobAs a Microbiology Manager, you will be responsible for the professional and administrative management of the laboratories, reviewing and approving measurements performed in the labs, ensuring compliance with cGMP standards, and ensuring conformity during audits. Your responsibilities will include supporting, mentoring, and developing the microbiology teams (Microbiological Assay, Sterility and Endotoxin, Fermentation IPC). In this role, you will report to the Senior Director, Quality Services Budapest.Main ResponsibilitiesManage 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 recurrenceAdhere to the current EHS / KIR / MEBIR requirements and standardsEnsure cGMP compliance and provide administrative and professional management of the QC Microbiological laboratoriesEnsure compliance with Hungarian and international pharmacopeiasFoster continuous improvement and develop solutions to address issues, improve processes and quality metricsDrive projects to completion by proposing solutions, gathering feedback from stakeholders, identifying areas which need escalation and sharing lessons learnedWrite and revise SOPs as required for this job function. Circulate for review, incorporate/address reviewer comments appropriately and ensure timely approvalEscalate issues or potential Quality Events in a timely mannerMaintain and continuously develop knowledge of global GxP regulations and guidelines, and utilize this expertise to make quality decisionsFoster Team Leaders, create positive atmosphere and build a good working culture. Manage 3 teams within a department of 20 employeesHave a holistic overview about the QC activities and their impacts on the related different departmentsWhat We ExpectBSc or MSc in a relevant scientific field (preferably biology, bioengineering, microbiology, or food engineering)Minimum of 5 years of Pharma cGMP experienceMinimum 3-5 years of leadership experience in a QC laboratoryQC experience in a regulated industryExcellent written and oral communication skillsExcellent analytical abilities and problem-solving skillsAbility to provide leadership role modelling, set priorities, and be accountable to timelinesExcellent soft skills, including communication, teamwork, and adaptabilityFluent in Hungarian and English, both written and oralGood record-keeping skills and writing abilitiesWorking knowledge of various computer software such as Labware LIMS and TrackWise What We OfferCompetitive compensation and benefit package (including a company car and management health check-up)„Nordic-style” culture – dynamic teamwork, good working atmosphere, flexibility, maintaining work-life balanceOpportunity to learn and developGood team spirit and friendly colleaguesStable international company backgroundMultinational working environmentHome office opportunity