As the QMS System Owner you will play a critical role within the Quality e-Systems team, being responsible for the oversight and management of the Quality Management System (QMS) across multiple sites. You will act as the subject matter expert (SME) during regulatory inspections, ensures compliance with quality standards and regulatory requirements, and managing small to medium-scale projects related to e-systems quality initiatives.

Your responsibilities include, but are not limited to:

• Manage the Quality Management System (QMS) for e-systems: Oversee the development, implementation, and maintenance of the QMS, ensuring alignment with regulatory requirements, industry standards, and company policies;
• Serve as Subject Matter Expert (SME): Act as the primary point of contact and SME during regulatory inspections and audits, providing support and guidance on e-systems compliance matters;
• Project Management: Lead and execute small to medium-scale projects related to e-systems quality initiatives, including system upgrades, process improvements, and validation activities;
• Documentation Control: Ensure the accuracy, completeness, and integrity of documentation within the QMS, including policies, procedures, work instructions, and other relevant documents;
• Change Management: Manage change control processes for e-systems, including assessment, approval, and implementation of changes to ensure compliance with regulatory requirements;
• Training and Communication: Provide training and support to staff on QMS procedures, processes, and compliance requirements, and communicate updates and changes effectively across the organization;
• Risk Management: Conduct risk assessments and collaborate with stakeholders to identify and mitigate risks associated with e-systems and QMS processes;
• Continuous Improvement: Drive continuous improvement initiatives within the QMS, identifying opportunities for optimization, efficiency gains, and enhanced compliance;
• Collaboration: Collaborate with cross-functional teams, including IT, Quality Assurance, Regulatory Affairs, and Operations, to ensure alignment of QMS processes with overall quality objectives and business needs;
• Documentation and Reporting: Maintain accurate and up-to-date records, generate reports as necessary, and provide metrics and insights on QMS performance to management and stakeholders.

If you have:

• At least 5 years of experience in a medicinal products manufacturing with strong experience in the field of compliance, various scale project management, knowledge of IT processes and systems;
• Master’s or doctoral degree in one of the fields of biology, pharmacy, biotechnology, chemistry, chemical technology, chemical and process engineering, or completed university studies in medicine;
• Knowledge of GMP requirements and regulations regarding pharmaceutical products with a focus on computerized systems validation (CSV) principles and methodologies;
• Experience in implementation and management of quality systems in the pharmaceutical industry;
• Experience in implementation of e-Systems in regulated  in the pharmaceutical industry;
• Fluent in Polish and English spoken and written;
• Strong organizational and project management skills to be able to set up inspection readiness and compliance improvement programs;
• High leadership and communication skills. Ability to make decisions;
• Managerial maturity and the ability to think strategically and analytically;
• Organizational skills and the ability to work under pressure.

What we offer:

• Competitive salary; 
• Private healthcare;
• Life insurance;
• Pension plan above national standards;
• Relocation package;
• Additional free day;
• and more..