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 backup care options and on-demand tutoring
Adoption, surrogacy, and family-planning benefits
Paid time off, including:
• Vacation, sick time, and observed Company-wide holidays
• Paid volunteer time to participate within your community
• Discretionary winter holiday shut down
• Paid 4-week sabbatical after 5 years, and every 3 years thereafter
Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
Generous 401k match and Financial Planning supports
Moderna-paid Life, LTD, and STD insurance, as well as voluntary benefit options
Concierge service including home services research, travel booking, and entertainment requests
Free premium access to fitness, nutrition, and mindfulness classes including exclusive preferred pricing on Peloton fitness equipment
Free parking, subsidized parking, or subsidized commuter passes, depending on location
Location-specific perks and extras!
Notices
Moderna is a place where everyone can grow. If you meet the Minimum 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at accommodations@modernatx.com. (EEO/AAP Employer)
Moderna requires all new hires to be fully vaccinated against COVID-19 as of their start date and to receive all available booster shots once eligible. This requirement is a condition of employment, and it applies regardless of whether the position is located at a Moderna worksite or is fully remote. If you are unable to receive the COVID-19 vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
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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