About the Team

At RezonBio, we combine quality, technology, and data driven approaches to support the development of innovative biological solutions. Our Quality e Systems team is responsible for the development, maintenance, and compliance of key electronic systems that support laboratory and quality processes across the organization. We work closely with QC, QA, IT, and Operations, supporting regulatory inspections, driving digitalization projects, and developing systems that enhance operational efficiency.

We are now looking for a Quality e Systems Expert who will take on the role of LIMS System Owner and become a key subject matter expert within our quality systems landscape.

Your Role

In this position, you will be responsible for:

• Managing the LIMS system across multiple sites, including its development, implementation, and maintenance in alignment with regulatory requirements and internal standards

• Acting as the primary subject matter expert during regulatory inspections and external audits

• Leading and executing small to medium scale projects related to quality e systems, including upgrades, validation activities, optimizations, and process improvements

• Ensuring the accuracy and integrity of system documentation and QMS related documents

• Overseeing change control processes related to LIMS and ensuring compliant implementation of system changes

• Participating in incident and deviation management, including leading investigations and implementing corrective and preventive actions

• Conducting risk assessments and collaborating with stakeholders to minimize risks related to e systems and QMS processes

• Driving continuous improvement initiatives, identifying opportunities for optimization and enhanced compliance

• Collaborating with IT, QA, QC, and Operations to ensure LIMS functionality meets business and process needs

• Preparing reports, metrics, and insights regarding LIMS performance and communicating them to stakeholders

Our Expectations

Education: Master’s or doctoral degree in biology, biotechnology, pharmacy, chemistry, chemical technology, chemical engineering, or a related scientific field

Professional Experience

• At least 5 years of experience in the pharmaceutical or biotechnology industry

• Strong background in compliance, quality systems, and IT related project management

• Experience implementing and managing e systems in a regulated environment

Key Competencies

• Solid knowledge of GMP requirements and computerized systems validation CSV methodologies

• Strong organizational and project management skills, including the ability to operate under pressure

• Excellent communication and leadership abilities

• Analytical and strategic thinking skills

• Fluency in both Polish and English, spoken and written

Benefits

• Lux Med private medical care
• Supplemental life insurance
• Flexible Flex Benefits system with a monthly budget
• Cafeteria platform
• Employee Pension Scheme (PPE) and Employee Pension Support (PWE)
• Accident insurance for employees' children
• Occasional Bonuses
• Extra day off per year
• Free employee transport (Duchnice)
• Co-financing of training and upskilling
• Fruit and vegetable days
• Employee canteen with hot meals and live cooking (Duchnice)
• Psychological support
• Office massages
• Co-financing of leisure for employees and their children
• Benefits from the Social Insurance Fund
• Occasional gifts.