Sr. Business Process Manager, Digital Quality at ModernaTX, Inc. in Norwood, Massachusetts

Job Description:

The Role



In this role, you will report to and work closely with the Director, Digital Quality to design, deploy and manage our expanding portfolio of digital quality management systems that support Quality and batch release processes. This role will help shape and deliver the long-term strategic vision for the Quality QMS Digital roadmap. This opportunity is unique in the pace and speed we expect and achieve.



Who You Are:



You are passionate about quality, continuous improvement, and enhancing systems to ensure optimal user experience and business efficiency. A master integrator gifted in bringing together people, concepts, and business goals with best-in-class execution. You thrive in a fast-paced environment and are comfortable rolling up your sleeves - if a process doesn't exist yet, you define it. You collaborate well amongst a team of expert peers.



Here's What You'll Do

• Drive the execution of complex projects - proactively identifying risks / mitigation strategies while communicating to stakeholders and driving timelines through a blend of project management, technology, and business process expertise.
  
  


• Execute on our Digital Quality strategy with clear communication, prioritization, and escalation, both within Digital Quality and other cross functional teams
  
  


• Mentor a team of internal and external business analysts and software engineers designing, implementing, and maintaining our electronic quality management system, Veeva Quality
  
  


• Partner with digital stakeholders to ensure successful planning and integration of key systems into the quality management system while looking out for automation capabilities, and any artificial intelligence initiatives.
  
  


• Foster a culture of innovation within the team and with stakeholders to challenge the status quo leveraging both new technologies and creative solutions within existing systems.
  
  


• Support the Digital Quality Leadership Team by managing action plans and project plans to deliver short-, mid-, and long-term quality goals.
  
  


• Apply an operational excellence mindset to help Identify, devise, and recommend new opportunities to optimize current processes.
  
  


• Define and deliver a consistent systems governance methodology across applications with clear roles and responsibilities established throughout the system lifecycle: Implementation, Enhancement, and Support
  
  


• Ensure GxP compliance is built into the design, delivery, and maintenance of all systems.
  
  


• Maintain inspection readiness through adherence to internal quality policies, procedures, and training.
  
  


• Participate in internal and external audits as digital quality expert for portfolio of processes.
  
  


• Hit the ground running immediately and work closely with various stakeholders in Quality to enable sustainable commercial operations.
  
  

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

• Bachelor's degree in science, technology, or another relevant academic discipline
  
  


• 8-10 years of experience designing implementing and maintaining electronic quality management systems to support compliance processes in a regulated biotech or Pharma company.
  
  


• Experience with GAMP and GxP compliance regulations
  
  

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

• Strong understanding of batch release, quality management workflows, and related processes
  
  


• Demonstrated experience defining, scoping, and managing technology initiatives; exceptional skills at facilitating teams and building consensus with membership comprised of diverse levels and areas of the company.
  
  


• Proficient in relevant project management software: Smartsheet, Excel, PowerPoint, Word, OneNote, MS Teams, etc. in addition to general knowledge with shared work environments
  
  


• People-oriented
  
  


• Extremely organized.
  
  


• Creative/innovative/problem solver that actively drives progress.
  
  


• Passion for people management and development in matrix teams
  
  


• Outstanding communication, presentation, and writing skills and ability to tailor messaging to audience.
  
  


• Ability to manage multiple projects in a fast-paced environment.
  
  


• Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
  
  


• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
  
  
  

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options


• Flexible Spending Accounts for medical expenses and dependent care expenses


• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities


• Family care benefits, including subsidized back-up care options and on-demand tutoring


• Free premium access to fitness, nutrition, and mindfulness classes


• Exclusive preferred pricing on Peloton fitness equipment


• Adoption and family-planning benefits


• Dedicated care coordination support for our LGBTQ+ community


• Generous paid time off, including:
  • Vacation, sick time and holidays
  • Volunteer time to participate within your community
  • Discretionary year-end shutdown
  • Paid sabbatical after 5 years; every 3 years thereafter


• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents


• 401k match and Financial Planning tools


• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options


• Complimentary concierge service including home services research, travel booking, and entertainment requests


• Free parking or subsidized commuter passes


• Location-specific perks and extras!

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 proud to be an equal opportunity workplace and is an affirmative action employer.


Moderna is committed to equal employment opportunity 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. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.


Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.


Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation 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 team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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