Specialist, Clinical Quality

The Role: (Summary)

The Specialist, Quality Assurance, will be part of a cohesive team responsible for supporting cGMP mRNA drug substances produced internally at Moderna. This role provides quality oversight and expertise to ensure technical success while adhering to a stringent Quality System that complies with global regulatory expectations.

Key Responsibilities and if appropriate Authorities of the Position may include:

• Demonstrate general knowledge of standard manufacturing compliance, quality disposition, and quality system review.

• Partner closely with peers for the disposition of Plasmid, Drug Substance, and Drug Product.

• Participate in quality-focused teams across Moderna's broad ecosystem of functions.

• Author and review SOPs, policies, and batch production/testing records to ensure compliance with cGMP operations.

• Oversee and review executed electronic and paper batch record documentation.

• Review manufacturing deviations and enforce adherence to current good manufacturing practices, SOPs, and manufacturing documentation and operations including modeling clean room behaviors.

• Establish and follow written procedures for the clear and accurate documentation of equipment operation, process instructions, and process data.

• Responsible for training adherence

• Adherence to data integrity principles

• Escalation of manufacturing, safety and quality concerns to department management

• Monitor process operations to ensure compliance with specifications.

• Practice safe work habits and adhere to Moderna's safety procedures and guidelines.

• Utilize knowledge to improve operational efficiency.

• Participate in the quality oversight of manufacturing through real-time observations of activities.

• Oversee review and release of Raw Materials and streamline procedures for the rejection and destruction of Raw Materials and Consumables.

• Identify, classify, and report deviations as appropriate.

• Develop batch records, SOPs, and training materials for startup activities.

• Participate in internal audits for compliance with SOPs, GMPs, and regulations. Basic understanding of health authority regulations and how to apply them internally.

• Leads projects with cross functional teams, able to lead and manage projects end to end. Ability to contribute to continuous improvement projects and support multiple projects at the same time.

• Act as a SME and resource for new hires

• Problem solving for complex issues and ability to drive corrective action

Required Background:

• Education: Bachelor's Degree or equivalent years of experience

• Experience: 2-5 Years experience in the biotechnology/biopharmaceutical industry, or other regulated industry. Preferably in Quality Assurance and/or Training / document control.

• Specific Certifications or Training: None

• Other Quantifiable Preference:

• Knowledge of FDA, EU, ICH guidelines, and relevant regulations.

• Experience with quality systems, including batch record review, deviation management, and change control.

• Proficiency in authoring and reviewing GMP documentation.

• Familiarity with environmental monitoring and microbiological testing.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options

• Flexible Spending Accounts for medical expenses and dependent care expenses

• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities

• Family care benefits, including subsidized back-up care options and on-demand tutoring

• Free premium access to fitness, nutrition, and mindfulness classes

• Exclusive preferred pricing on Peloton fitness equipment

• Adoption and family-planning benefits

• Dedicated care coordination support for our LGBTQ+ community

• Generous paid time off, including:

• Vacation, sick time and holidays

• Volunteer time to participate within your community

• Discretionary year-end shutdown

• Paid sabbatical after 5 years; every 3 years thereafter

• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents

• 401k match and Financial Planning tools

• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options

• Complimentary concierge service including home services research, travel booking, and entertainment requests

• Free parking or subsidized commuter passes

• 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 contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)