2025 Co-Op, R&D Quality and Compliance

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 Fall co-op program will run from July 14 – December 12, 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 the preparation of audit-related documents, providing support during Health Authority inspections as needed, and helping track timelines related to audit reports, CAPA actions and Issue Management. Additionally, this role will assist with the verification and maintenance 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 study, vendor and pharmacovigilance 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: 

• Assist with entering and tracking inspection activities in Veeva. 

• Contribute to continuous improvement initiatives aimed at optimizing RDQ&C audit processes and tools. 

• Support data oversight and audit record management within the Veeva Audit Management System. 

• Assist with CAPA and Issue Management activities. 

• Aid in site selection and audit scheduling. 

• Train in conducting clinical study, vendor and pharmacovigilance audits (non-travel). 

• Assist in developing documentation for Moderna-conducted audits. 

• Support preparation efforts for Health Authority inspections as needed. 

• Contribute to Quality Optimization initiatives, including training administration, procedural documentation, and metrics/reporting.

• Enhance regulatory knowledge by contributing to the development of quarterly newsletter and regulatory intelligence activities.

• Gain insights into Quality study team support.

• Accept constructive feedback and actively seek opportunities for professional growth. 

• Participate in various departmental activities and attend relevant meetings as required.

• Competencies and Benefits of this role:

• 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 Will 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

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