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.

Heres What Youll 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.

Heres What Youll Need (Minimum Qualifications)

• Bachelors 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.

Heres What Youll 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. Thats why our global benefits and well-being resources are designed to support youat 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.

About Moderna

Since our founding in 2010 we have aspired to build the leading mRNA technology platform theinfrastructure 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 peopleare the driving force behind our scientific progress and our 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 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 persons 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.

Were 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 .