Sr. Manager, Quality Services

The Role

In this role, you will provide oversight, strategic direction, management support and guidance for building and maintaining Moderna’s R&D Quality Management System (QMS), with a focus on training administration to support GCP/GLP, GCLP/GVP/CSV activities conducted by Moderna and its service providers.  You will be responsible for establishing training strategies/programs to drive optimal performance of the R&D QMS through management of key projects and programs impacting Moderna’s Learning Management System (LMS), ensuring consistent implementation of training related deliverables across the R&D organization and proactive identification and mitigation of potential risks impacting the QMS from a training perspective .  Additionally, you will support the appropriate integration a oversight of the R&D QMS within the Moderna Global QMS. The appointee will also be responsible to champion a quality culture within the R&D organization and drive toward a sustained state of inspection readiness.

Here’s What You’ll Do

• Oversee daily administration of the Learning Management System (LMS) in support of RDQ and the R&D organization

• Partner with R&D functional leaders to facilitate development, plan implementation and support ongoing lifecycle management of the functional training program for the respective teams

• Collaborates with R&D Functional Process and Training Leads to define ways of working and ensure alignment and consistency when leading activities to support the administration of the overall R&D training program

• Lead and contribute to strategic and operational improvement initiatives impacting the QMS

• Supports oversight of the R&D training program to ensure overall effectiveness by meeting established KPIs

• Manage and/or own training related CAPA activities originating from R&D Issues, change controls, audits, inspections, etc., as appropriate

• Actively participate as a Subject Matter Expert for health authority inspections of Moderna as it relates to the R&D QMS for training

• Provide active R&D representation/participation in the Global QMS organization to ensure appropriate R&D GxP integration.

• Contribute to the continuing development of a quality culture at Moderna.

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

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

• BS/BA, MS or PhD and a minimum of 10-12, 8-10, years’ experience, respectively, in Biotech, Pharma or Clinical Research Organization.

• Previous experience with a validated LMS and document management system (e.g. SAP SuccessFactors and Veeva Quality)

• Knowledge of metrics and data analytics best practices as they relate to measuring training program effectiveness.

• Demonstrated ability to effectively influence decisions without direct authority and working in a matrix environment

• Expert level knowledge of Excel, PowerPoint and other office applications.

• Strong knowledge of relevant FDA, EU, ICH GCP guidelines.

• Knowledge of relevant FDA, EU, ICH guidance for GVP, GCP, GCLP/GLP, and CSV

• Experience working with CROs, vendors, and relationship management.

• Strong interpersonal skills and ability to interact effectively with all levels within the organization.

• Ability to solve complex problems taking a broad perspective to identify innovative solutions.

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

• Ability to collaborate effectively 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 provides employees with a comprehensive and innovative suite of benefits, including:

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

• Dedicated guided healthcare coordination through Included Health that elevates healthcare planning for every kind of employee, including our LGBTQ+ employees and other underserved communities

• Flexible Spending Accounts for medical expenses and dependent care expenses

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

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

• Family care benefits, including subsidized back