Associate Director, Digital Quality Systems Management

6 days ago

Norwood, Massachusetts, United States Moderna Full time
About the Role

We are seeking an experienced Associate Director to lead our Digital Quality Systems Management team. As a key member of our organization, you will be responsible for overseeing the management of our GxP systems, ensuring compliance with regulatory requirements, and driving continuous improvement in our digital operations.

Key Responsibilities
  • Lead and coordinate Application Management Services (AMS) for Digital Quality GxP Systems, ensuring compliance with regulatory requirements and company standards.
  • Develop and maintain Support and Service models for various Digital Quality Products, including Veeva Docs/QMS, LabVantage LIMS, and others.
  • Accountable for problem resolution related to application issues across business units and regions, working with Digital Quality Product Owners, business colleagues, and external partners.
  • Manage and oversee 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.
Requirements
  • 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.
About Moderna

Moderna is a leading biotechnology company that is committed to changing the future of medicine. We are a place where everyone can grow, and we are proud to be an equal opportunity workplace and an affirmative action employer. We are 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.

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