Business Process Manager, Quality Systems

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
• Savings and investments
• 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.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.  

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. 

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. 

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. 

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. 

Moderna is a smoke-free, alcohol-free, and drug-free work environment. 

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! 

Moderna is committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. 

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. 

Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at leavesandaccommodations@modernatx.com. 

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