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Business Process Manager, Quality Systems, Warsaw

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Client:

Moderna

Location:

Warsaw, Poland

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

79e5ba19af4b

Job Views:

5

Posted:

11.08.2025

Expiry Date:

25.09.2025

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Job Description:

In this role, you will implement, administer, and maintain a portfolio of digital Quality Systems that support end-to-end Quality processes. You will be responsible for managing system configurations, executing validation and testing activities, and supporting integrations across platforms. This includes overseeing day-to-day operations, user access and role management, issue resolution, and system enhancements for global validation tools, testing platforms, and quality systems. You will also contribute to continuous improvement efforts, ensuring that systems remain compliant, efficient, and aligned with evolving business and regulatory needs.

Here’s What You’ll Do

• Manage end-to-end delivery of digital Quality initiatives, with a focus on validation solutions. Proactively identify risks, develop mitigation strategies, and ensure timeline adherence through a combination of technical insight, business process understanding, and project management skills.
• Collaborate with Digital and cross-functional teams to plan, implement, and integrate validation and QMS platforms. Identify opportunities for automation and AI-driven capabilities to enhance system performance and compliance.
• Serve as the technical lead and administrator for the electronic validation management system (Kneat), including:
  • Best practices implementation for Computer System and Commissioning Qualification Validation in Kneat
  • Configuration and enhancement deployment
  • System administration: role-based access control and data governance
  • Operational support and issue resolution
  • Training, user guidance, and documentation maintenance
  • Metrics reporting and dashboard development
• Provide system administration support for additional Quality platforms including Veeva (Document and Quality Management), testing tools (e.g., Tosca), and other internal systems. Ensure consistent operations and user support.
• Evaluate and prioritize enhancement requests. Apply a continuous improvement mindset to streamline workflows, enhance user experience, and maintain system health and performance.
• Perform validation and qualification activities for system implementations and changes, aligned with SDLC and GxP requirements.
• Maintain and improve data models and integrations across systems to ensure scalability and data integrity.
• Support audit and inspection activities by ensuring documentation, processes, and systems remain inspection-ready and in full compliance with internal policies and external regulations.
• Support strategic initiatives by maintaining clear communication, prioritizing tasks effectively, and escalating issues when appropriate. Collaborate closely across Quality, Digital, and functional teams.
• Adhere to all relevant GxP regulations, industry guidelines, and company SOPs. Ensure system activities are consistently aligned with compliance requirements.
• Manage multiple concurrent tasks and contribute to broader team goals and special initiatives as needed.

Here’s What You’ll Need (Minimum Qualifications)

• Bachelor’s degree in science, technology, or a related discipline.
• 7+ years of experience in Quality Systems implementation and maintenance in a regulated biotech or pharmaceutical environment.
• Minimum 4 years of experience with Kneat (configuration, administration, and support).
• Solid understanding of system validation tools and SDLC methodologies.
• Proven ability to execute computer system validation (CSV) in compliance with industry standards.
• Awareness of trends and technologies in document and validation management systems.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• 2+ years of hands-on experience with Veeva and Tosca configuration.
• Familiarity with project management tools and frameworks (e.g., Jira).
• Experience with APIs, data reporting, and system integrations.
• Strong interpersonal and communication skills with the ability to influence across functions.
• Working knowledge of FDA, EU, and ICH regulations related to CSV and data integrity.
• A passion for making an impact in a high-growth, fast-paced organization that values being Bold, Relentless, Curious, and Collaborative.

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to well-being
• Free premium access to fitness, nutrition, and mindfulness classes
• Family planning and adoption benefits
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savingsandinvestments
• Location-specific perks and extras!

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

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