2025 Co-Op RD Quality and Compliance

The Role:
Modernas R&D Quality and Compliance (RDQ&C) group is seeking a highly motivated college student that has an interest in Digital Quality Assurance and Laboratory Quality in the RDQ&C environment within the biotech/pharma industry. This position provides an opportunity for inquisitive students who are currently pursuing a degree in Life Sciences Computer Science Engineering Data Science or related field to get hands on experience working with the RDQ&C Digital Quality team and RDQ&C Laboratory Quality team in a fastpaced environment providing proactive digital compliance guidance and support across all RDQ&C GXPs (GCP/GLP/GVP/CSV).

The RDQ&C CoOp role will support the integrity security and performance of digital systems in Modernas R&D operations ensuring that laboratory clinical and pharmacovigilance systems comply with regulatory requirements for electronic records and signatures. Additional contributions include reviewing assay method validation documents and results for clinical sample analysis for study specific regulated processes and opportunity to support audits for laboratory deliverables.

The ideal candidate will have a good understanding of health authority regulatory requirements digital system validation lifecycle controls and the drug development process as well as Quality Assurance (QA) clinical development and clinical sample analysis and electronic record/electronic signature regulations and guidelines.
If you are bold relentless collaborative and obsess over learning a coop program at Moderna can help augment your education and accelerate your career.

Our Fall coop program will run from July 14 December 12 2025. All applicants must be available to work fulltime and on site (Norwood MA) for the entire duration of the program.

Heres What You Will Do:

• Support QA audits of digital systems and laboratory deliverables providing QA oversight for digital system implementations while gaining firsthand experience with GCP GLP GVP 21 CFR Part 11 and ISPE GAMP 5 compliance.

• Assist in validation and lifecycle management compliance to meet regulatory standards.

• Collaborate with team members to develop and maintain R&D digital systems compliant with regulations and guidelines.

• Learn QA oversight best practices for digital system implementation phases.

• Review validation documentation to ensure quality and compliance.

• Contribute to risk impact assessments and evaluate potential digital system risks.

• Identify and resolve digital system compliance issues under guidance.

• Overview of audit study materials and reports for nonclinical biomarker and bioanalytical studies.

• Assist audit team with audit deliverables CAPAs and responses.

• Competencies and Benefits of this role:

• Collaborate with experienced team members to build expertise in compliance implementation.

• Build capabilities in providing QA oversight and competencies in ensuring compliance for essential documents and records.

• Develop a strong understanding of the audit process and gain opportunities to shadow auditors building foundational skills for independently assessing compliance.

• Learn principles for conducting risk impact assessments for digital systems.

• Gain insight into compliancerelated issues to understand common challenges and solutions in regulatory compliance.

• Continuously expand technical and regulatory knowledge in software validation and technological advancements.

• Work closely with seasoned R&D Quality and Compliance professionals gaining mentorship across diverse perspectives and experiences.

• Receive training and experience with R&D Quality across the various GXPs (GCP/GLP/GVP/CSV).

• Gain exposure to various GXP functional groups supported by RDQ&C.

Heres What You Will Bring to the Table:

• Currently pursuing a degree in Life Sciences Computer Science Engineering Data Science or a related field.

• Bioanalytical technology knowledge including but not limited to LIMS PCR plate readers and mass spectroscopy proficiency is highly desired

• Basic familiarity with pharmaceutical regulations (GCP GVP GLP CSV) is a strong plus.

• Basic familiarity with Electronic Record and Electronic Signature requirements including 21 CFR Part 11 regulation and ISPE GAMP 5 guidelines.

• Technical knowledge in Machine Learning and Artificial Intelligence preferred.

• Understanding of computer system validation and system lifecycle controls.

• Prior experience or coursework in Quality Assurance is a plus.

• Strong analytical and critical thinking skills with excellent communication and teamwork abilities.

• Strong attention to detail with a dedicated commitment to upholding quality standards.

• Eagerness to learn be mentored and continuously improve.

• Ability to work both independently and collaboratively in a fastpaced demanding environment.

• Skilled in multitasking and prioritizing tasks in response to shifting demands.

• Willing and able to relocate to Norwood MA for the coop

• Indefinite right to work in the United States without the need for sponsorship now or in the future.

At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global wellbeing resources are designed to support youat work at home and everywhere in between.

• Free premium access to meditation and mindfulness classes
• Subsidized commuter benefits
• Generous paid time off including:
  Vacation sick time and holidays
  Volunteer time to participate within your community
  Discretionary yearend shutdown
• Locationspecific 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 worldclass 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 inperson culture is critical to our success. Moderna champions the significant benefits of inoffice collaboration by embracing a 70/30 work model. This 70 inoffice 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/careers to learn more about our current opportunities.

Moderna is a smokefree alcoholfree and drugfree 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 committed to equal employment opportunity and nondiscrimination for all employees and qualified applicants without regard to a persons 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 EVerify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.

Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can 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 . (EEO Employer)