2026 Co-op, R&D Quality (GxP)
About The Position
This is a fall Co-op opportunity in Cambridge, MA from July 13, 2026 – December 11, 2026. Applicants must be available for the entire duration of the Co-op. Start date will be July 13, 2026. Moderna’s R&D Quality (RDQ) group is seeking a highly motivated college student that has an interest in Quality Assurance in the RDQ 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 team in a fast-paced environment providing proactive compliance guidance and support across all RDQ GXPs (GCP/GLP/GVP/CSV). The R&D Quality 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. The R&D Quality Co-op will support RDQ staff across R&D Quality initiatives, contributing to process enhancement, operational support, and quality system activities. The role will assist with GxP CAPA and Issue Management, support Health Authority inspection readiness activities as needed, and help maintain oversight of audit data and records within the Veeva Audit Management System. The Co-op will also have the opportunity to observe experienced RDQ Auditors conducting audits, as scheduling permits. Success in this position requires strong communication skills and the ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Requirements
- Currently enrolled as a student working towards a bachelor’s degree in a science focused program (e.g., 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
- Excellent organizational skills and ability to manage multiple priorities
- Proficient with Microsoft Office/365 (Excel, Word, PowerPoint)
- This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.
- Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship.
Nice To Haves
- Interest and foundational understanding of clinical trial quality concepts such as audit readiness, inspection readiness, and quality risk thinking (coursework/internship/project exposure welcomed)
- Knowledge of ICH-GCP principles and ability to apply them in real-world scenarios (e.g., documentation expectations, traceability, data integrity)
- Comfort working in regulated electronic systems (e.g., Veeva and/or similar QMS/eTMF/document systems) with attention to data accuracy and record completeness
- Strong analytical and reporting skills: ability to build/maintain trackers, use Excel to summarize trends, and communicate insights to stakeholders
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Responsibilities
- Contribute and support continuous improvement initiatives in the Quality space (e.g., AI projects) that will focus on evaluating and streamlining audit processes and tools
- Support oversight of data and audit records in the Veeva Audit Management System
- Support CAPA and Issue Management across all GxPs
- Support site selection and audit scheduling
- Train in the conduct of 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 current regulatory and quality expectations by supporting oversight of audit records and data integrity within the Veeva Audit Management System.
- 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
Benefits
- Free premium access to meditation and mindfulness classes
- Subsidized commuter benefits
- Generous paid time off, including vacation, sick time, holidays, volunteer days, and a discretionary year-end shutdown
- Location-specific perks and extras
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What This Job Offers
Job Type
Full-time
Career Level
Intern
