Associate Director, GxP Systems Application Management Services at ModernaTX, Inc. in Norwood, Massachusetts

Job Description:

The Role



In this role, you will lead and coordinate Application Management Services (AMS) for the Digital Quality GxP Systems within the CMC Digital Organization, supporting cGMP manufacturing and quality activities to ensure on-time and in-full deliveries. This role encompasses the responsibility to oversee all operational activities, ensuring they meet company standards and regulatory requirements, while driving continuous improvement and operational efficiency. The Associate Director will primarily focus on managing application services operations and support, working with cross-functional teams and Digital Quality Product Owners delivering upgrades, enhancements, new modules, and other systems development initiatives.


You are passionate about quality, continuous improvement, and enhancing systems to ensure optimal user experience and business efficiency. 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 and a cross functional quality operations userbase.



Here's What You'll Do

• Supervise Application Management Services (AMS) to ensure the Digital Quality Product ecosystem is effectively managed and remains GxP compliant.
  
  


• Develop, maintain, and continuously optimize Support and Service models for a variety of Digital Quality Products such as Veeva Docs/QMS, LabVantage LIMS, KNEAT, MODA EM-LIMS, Chromeleon Chromatography Data System, Benchtop Quality Control Instrumentation Systems, Automation Systems (Hamilton, Andrew+), etc.
  
  


• Accountable for problem resolution related to application issues across business units and regions; this includes working with Digital Quality Product Owners, business colleagues, business-facing IT colleagues, infrastructure teams, external partners, and/or vendors.
  
  


• Manage, oversee, and engage with external AMS Managed Service Providers (MSP) to ensure high-quality service delivery and adherence to SLAs.
  
  


• Oversee incident management, required escalations, and drive resolution for incidents impacting Digital Quality Products.
  
  


• Engage L3 technical/functional software support as required throughout product and project lifecycles.
  
  


• Proactively resolve service delivery, quality, process, resource, and performance issues by monitoring and analyzing usage data and metrics.
  
  


• Regularly report on performance, including status, issues, and risks, to leadership.
  
  


• Collaborate with Digital IT core support services and operations as required.
  
  


• Ensure Digital Quality Product owners maintain adherence to required periodic activities such as user reviews, backup/restore/disaster recovery challenges, patching cycles, periodic reviews, etc.; this includes optimizing the AMS team on delivery of these tasks and engaging related partners in the digital, business, and quality areas in collaboration on execution.
  
  


• Manage routine maintenance activity to ensure reliable and effective operation of the key platforms and services in the application portfolio.
  
  


• Support product owners in executing on Software Development Life Cycle (SDLC) management through routine systems health assessment, maintenance of high-quality documentation, and license management.
  
  


• Cultivate and maintain the informational IT knowledge-base containing documentation of applications, policies, procedures, infrastructure, and other critical technology assets.
  
  


• Ensure change management processes are continuously followed to maintain a stable production environment.
  
  


• Focus on quality and compliance within the manufacturing and operations areas.
  
  


• Use risk-based analysis to create and revise procedures to align with current regulatory requirements.
  
  


• Being a 24/7 global operation, work outside of core hours and on weekends may be required.
  
  


• Additional duties as may be assigned from time to time.
  
  

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

• Bachelor's degree in Computer Science, Information Technology, Engineering, or a related field.
  
  


• Minimum of 12 years of experience in GxP systems management and digital operations.
  
  


• Proven experience in managing application services and working with external service providers.
  
  


• Strong understanding of cGMP manufacturing and quality assurance processes.
  
  


• Demonstrated ability to lead cross-functional teams and manage complex projects.
  
  


• Excellent problem-solving, organizational, and communication skills.
  
  


• Experience working with Digital systems hosted in cloud and understanding of connectivity between on-prem systems and SAAS/Cloud.
  
  

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

• Advanced degree in a related field.
  
  


• Extensive experience with Software Development Life Cycle (SDLC) management.
  
  


• Strong understanding of core laboratory systems, related processes, and quality management workflows
  
  


• Knowledge of regulatory requirements and risk-based analysis.
  
  


• Experience in a pharmaceutical or biotechnology environment.
  
  


• Strong analytical skills with experience in data-driven decision making.
  
  


• Ability to work collaboratively in a high-growth, fast-paced 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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