Job description
The RoleThis 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
Manage quality personnel and oversees their selection, performance management, mentoring and career development
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.
Elevate Moderna’s overall self inspection program to ensure audit readiness and operations are performed in a compliant manner
Responsible for routine readiness walkthroughs of all areas of the site to ensure continued state of inspection readiness
Provide cross functional quality oversite for quality investigations, validation, data integrity and cGMP compliance
Collaborate cross functionally to build out an inspection program to ensure compliance with local and global health authorities
Support site regulatory inspections in the creation, maintenance and management of inspection material, ensuring it is organized, current and readily accessible at all times.
Work collaboratively with commitment owners to ensure that all commitment timelines are met and confirm their timely closure and ensure suitable effectiveness checks are in place
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.
Drive process enhancements to gain efficiencies as they relate to Deviations and CAPAs
Participate in Deviation Review Board, Change Review Board and CAPA review board initiatives
Work collaboratively with the digital team on the GXP integrated digital landscape to support all electronic systems.
Participate in internal audit program and third party/regulatory inspection programs for the Norwood cGMP manufacturing facility. Maintain audit responses and audit trending.
Participate in Management Review Meetings
Perform Annual Product Reviews
Additional duties as may be assigned from time to time
Here’s What You’ll Need (Minimum Qualifications)
Minimum of 6-8 years experience in a GMP manufacturing environment with a Bachelor’s degree, or 5 years of experience with a Master’s degree in Biology, Chemistry, Chemical Engineering, Biomechanical Engineering, Bioengineering, Biomedical Engineering, BioChemistry or related field.
Experience providing QA support and/or oversite to manufacturing operations
Here’s What You’ll Bring to the Table (Preferred Qualifications)
Preferred skills include working knowledge of Regulatory Affairs
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
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
- D iscretionary year-end shutdown
- Paid sabbatical after 5 years; every 3 years thereafter
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
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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
-
gatheringourvoice.org is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, gatheringourvoice.org provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, gatheringourvoice.org is the ideal place to find your next job.