Specialist, Quality Systems And Compliance

The Role:

This role is an exciting opportunity to be a part of the Quality Assurance organization. Moderna is a growing organization with a state-of-the-art cGMP manufacturing facility in Norwood, MA. The site focusses on manufacturing early phase and commercial product. As the company grows, the Quality Assurance Department is also growing and is looking for talented individuals with a strong Quality Culture and ability to adapt to a fast-paced environment. This role will take the lead for many of the responsibilities listed below and will be expected to see tasks to completion successfully with minimal oversight.

We work collaboratively as a team, we boldly strive for excellence, we are constantly curious and committed to ongoing learning and improvement, and we are relentless in our pursuit of having the highest level of Quality products.

Here’s What You’ll Do:

• Assist in improving and maintaining Moderna’s overall Quality Management System (QMS), including policies and procedures while keeping them current with emerging and changing regulations.
• Drive process enhancements to gain efficiencies as they relate to Quality processes.
• Work collaboratively with the digital team on the GXP integrated digital landscape to support all electronic systems.
• Lead site metric trending, including evaluation of trends and implementation of actions.
• Manage the performance and effectiveness of the quality system programs such as change management, discrepancy and CAPA management, training, documentation and records management, and data integrity.
• Partner with cross-functional teams to act against metrics as needed and ensure actions and improvements are driven.
• Support Quality Management Review, Annual Product Review, Deviation Review Board, Change Review Board and CAPA review board initiatives.
• Additional duties as may be assigned from time to time.

Here’s What You’ll Need (Minimum Qualifications)

• BA/BS degree (preferred) with at least 2 years of Quality Assurance working experience in pharmaceutical industry providing Quality Assurance oversight.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Working knowledge of eQMS.
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
• Demonstrated data analysis and analytical tool experience.

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

• Volunteer time to participate within your community
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• Dedicated care coordination support for our LGBTQ+ community
• Paid sabbatical after 5 years; every 3 years thereafter
• Vacation, sick time and holidays
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Highly competitive and inclusive medical, dental and vision coverage options
• Adoption and family-planning benefits
• Discretionary year-end shutdown
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Free premium access to fitness, nutrition, and mindfulness classes
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Generous paid time off, including:
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Exclusive preferred pricing on Peloton fitness equipment
• Free parking or subsidized commuter passes
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Location-specific perks and extras!

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

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 make a request to the Talent Acquisition Partner or contact the Accommodations team at [email protected]. (EEO/AAP Employer)

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