2025 Co-Op, R&D Quality and Compliance
ModernaTX, Inc.

Job Info

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The Role:

Moderna's 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 fast-paced environment providing proactive digital compliance guidance and support across all RDQ&C GXPs (GCP/GLP/GVP/CSV).

The RDQ&C Co-Op role will support the integrity, security, and performance of digital systems in Moderna's 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 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 (Norwood, MA) for the entire duration of the program.

Here's What You'll 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.
  

Here's What You'll Need:

• 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 compliance-related 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.
  

Here's What You'll 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 fast-paced, demanding environment.
  
• Skilled in multitasking and prioritizing tasks in response to shifting demands.
  
• Willing and able to relocate to Norwood, 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)

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