IT Quality Senior Expert

Bayer (Schweiz) AG; Gdańsk; Hybrid; PLN 80,000 - 120,000; Full time

Job summary

Bayer is seeking an IT Quality Senior Expert in Gdańsk to ensure quality compliance with suppliers, manage audit readiness, and support project management for validation teams. Candidates should have a relevant Bachelor's degree, experience in Quality or GxP, and strong communication and collaboration skills. This role offers potential for hybrid work and contributes to meaningful projects in a diverse environment.

Qualifications

• Relevant experience of 2-3 years in Quality or GxP.
• Strong Microsoft Office skills including Excel and PowerPoint.
• B2/C1 level of English, written and spoken.

Responsibilities

• Ensure quality and compliance of suppliers.
• Support project management for validation and qualification teams.
• Maintain audit readiness and manage documentation.

Skills

Quality

GxP

Communication

Collaboration

Detail-oriented

Education

Bachelor's degree in Medical/pharmaceutical/natural science/IT

Tools

Microsoft Office

SAP

Document management system

Job description

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

IT Quality Senior Expert

Job purpose:

To ensure the quality and compliance of suppliers, as well as to support audit readiness and project management for validation and qualification teams. This includes performing and updating supplier quality assessments, providing necessary documentation and evidence for audit scoping and planning, monitoring audit remediation activities, and maintaining audit readiness. Additionally, the activities involve supporting the creation and maintenance of Quality Assurance Agreements, initiating and following up on periodic reviews, and providing project management support to validation and qualification teams to ensure that all processes and documentation meet regulatory and quality standards.

Who you are:

• Bachelor's degree in Medical/pharmaceutical/natural science/IT background
• Professional experience (2-3 years) inQualityorGxPrelated area
• Experience in conducting training, ability to lead telecofnerences in an international context and to create project plans
• Knowledge of GxP relevant environment
• Familiarity with Audit or Risk Management beneficial
• Advanced Microsoft Office knowledge (e.g Excel, Word,Power Point)
• Intermediate experience in usage of digital collaboration tools (e.g Teams, SharePoint)
• Basic SAP and document management system knowledge
• English level B2/C1 written and spoken
• Detail-oriented with a focus on accuracy, compliance, and completeness in documentation and work result
• Willingness to learn and extend skills and knowledge among the team and cooperating with lower/middle management
• Communication and collaboration skills, with the ability to work effectively with cross-functional project teams across diverse cultures and geographies

What you do:

• Perform initial checks of IT supplier quality assessments to evaluate supplier performance and compliance with Bayer quality standards
• Update supplier quality assessments based on ongoing performance and compliance evaluations
• Coordinate with cross-functional teams to provide necessary documentation and evidence to support audit scoping and planning
• Monitor audit remediation activities of action plans, tracking progress, and ensuring timely and effective closure of audit findings
• Contribute to the development and enhancement of audit processes and remediation activities to drive continuous improvement
• Maintain audit readiness by keeping System Life Cycle files, incl. IT Quality Validation Master Plan (VMP) up-to-date and aligning with regulatory and compliance requirements
• Monitor external and internal IT framework and compliance requirements to ensure alignment with the IT MS
• Update the IT Management System to reflect changes in processes, standards, and compliance requirements
• Evaluate inspection findings and metrics of the set standards to drive continuous improvement of the IT Management System
• Support the creation and maintenance of Quality Assurance Agreements with suppliers, outlining quality expectations and requirements
• Initiate and follow up on periodic reviews, e.g. access rights, audit trails, services
• Provide project management support to validation and qualification teams, including maintaining project status reports and coordinating project activities
• Track and report the status of all validation and qualification activities, ensuring transparency and alignment with project timelines
• Collaborate with cross-functional teams to support the planning and execution of validation and qualification projects
• Ensure all project documentation is stored in accessible locations, maintaining organization and ease of access for project team members
• Contribute to continuous improvement initiatives to enhance project management processes and efficiency
• Train, guide, and consult project teams to ensure effective IT system operations and compliant documentation, providing support and expertise to enhance operational efficiency and compliance
• Prepare standardized KPI reporting’s

YOUR APPLICATION

Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination. Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. Bayer offers the possibility of working in a hybrid model. We know how important work-life balance is, so our employees can work from home, from the office or combine both work environments. The possibilities of using the hybrid model are each time discussed with the manager. Bayer respects and applies the Whistleblower Act in Poland.
Location:	Poland : Pomorskie : Gdańsk
Division:	Enabling Functions
Reference Code:	847119

Location:

Poland : Pomorskie : Gdańsk

Division:

Enabling Functions

Reference Code:

847119