Mikrobiológia Menedzser Budapest

Mikrobiológia Menedzser
Budapest

QC Microbiology Manager

About the Job

As 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 Responsibilities

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

What We Expect

BSc or MSc in a relevant scientific field (preferably biology, bioengineering, microbiology, or food engineering)

Minimum of 5 years of Pharma cGMP experience

Minimum 3-5 years of leadership experience in a QC laboratory

QC experience in a regulated industry

Excellent written and oral communication skills

Excellent analytical abilities and problem-solving skills

Ability to provide leadership role modelling, set priorities, and be accountable to timelines

Excellent soft skills, including communication, teamwork, and adaptability

Fluent in Hungarian and English, both written and oral

Good record-keeping skills and writing abilities

Working knowledge of various computer software such as Labware LIMS and TrackWise

What We Offer

Competitive 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 balance

Opportunity to learn and develop

Good team spirit and friendly colleagues

Stable international company background

Multinational working environment

Home office opportunity