The Role
Moderna’s R&D Quality and Compliance (RDQ&C) group is seeking a highly motivated college student that has an interest in Quality Assurance in the RDQ&C environment within the biotech/pharma industry. This position provides an opportunity for inquisitive students who are currently pursuing a Bachelor of Science degree (e.g., Biology, Chemistry, Pharmacy etc.) to get firsthand experience working with a R&D Quality and Compliance team in a fast-paced environment providing proactive compliance guidance and support across all RDQ&C GXPs (GCP/GLP/GVP/CSV). The R&D Quality and Compliance Co-Op will also contribute to key development projects and help advance the overall maturity of our program.
If you are bold, relentless, collaborative, and obsess over learning, a co-op program at Moderna can help augment your education and accelerate your career.
Our Spring co-op program will run from January 21 – June 20, 2025. All applicants must be available to work full-time and on site (Cambridge, MA) for the entire duration of the program.
The R&D Quality and Compliance Co-Op role will focus on assisting RDQ&C staff with continuous improvement initiatives in the Clinical Quality space. This position will also assist with GCP CAPA and Issue Management, support Health Authority inspections as needed, and will help support oversight of data and records in the Veeva Audit Management System. The Co-Op program will also provide the opportunity for the Co-Op to observe experienced RDQ&C Auditors in conducting clinical audits. The candidate must also possess the ability to effectively interact and collaborate in a dynamic, cross-functional matrix environment.
Here’s What You Will Do
- Contribute and support continuous improvement initiatives in the Clinical Quality space (e.g., AI projects) that will focus on evaluating and streamlining GCP audit processes and tools
- Support oversight of data and audit records in the Veeva Audit Management System
- Support GCP CAPA and Issue Management
- Support Quality Management Review (QMR) activities
- Support site selection and audit scheduling
- Train in the conduct of clinical (GCP) audits (non-travel)
- Aid in the creation of documentation for Moderna conducted audits
- Assist in preparation for Health Authority inspections, as needed
- Contribute to Quality Optimization efforts in training administration, procedural documents and metrics/reporting
- Learn about current regulatory requirements by contributing to the development of quarterly newsletter and regulatory intelligence activities
- Learn about Quality study team support
- Accept candid feedback and seek opportunities for self-improvement
- Engage in various departmental activities and attend relevant meetings as required
Here’s What You’ll Need
- Gain real life experience in a dynamic and growing R&D Quality and Compliance function that supports clinical trials, non-clinical laboratories and pharmacovigilance activities
- Work closely with seasoned R&D Quality and Compliance professionals that will provide excellent mentorship opportunities through a variety of lenses and experiences
- Receive training and gain direct experience with R&D Quality across the various GXPs (GCP/GLP/GVP/CSV)
- Gain a keen understanding of the audit process and opportunities to shadow auditors during audits
- Exposure to the various GXP functional groups that RDQ&C supports
Here’s What You’ll Bring To The Table
- Currently enrolled as a student working towards a bachelor’s degree in a science focused program (i.e., Biology, Chemistry, Pharmacy) or similar
- At least 3 years of study in one of the above scientific fields preferred
- Basic familiarity with pharmaceutical regulations (GCP, GVP, GLP, CSV) is a strong plus
- Must possess excellent organization skills and ability to manage multiple priorities
- Basic familiarity with Microsoft Excel, Word, PowerPoint, etc. is a plus
- Excellent verbal and written communication skills and the ability to interact professionally with a diverse group, executives, managers, and subject matter experts
- Willingness to learn, be mentored, and improve
- Ability to work independently and in collaborative team environments
- Ability to work in a fast-paced demanding environment
- Ability to prioritize based on shifting demands
- Ability to multitask and know when to ask for help
- Willing and able to relocate to Cambridge, MA for the co-op
- Indefinite right to work in the United States without the need for sponsorship now or in the future
Moderna is pleased to provide you with an innovative suite of benefits, including:
- Free premium access to meditation and mindfulness classes
- Free parking or subsidized commuter passes
- Generous paid time off, including:
- Vacation, sick time and holidays
- Volunteer time to participate within your community
- Discretionary year-end shutdown
- 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 the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
