Address The Role
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.
Moderna's strategic partnership with the UK Government is exemplified by our innovative presence at Harwell. Our mission is to establish a leading-edge research, development, and manufacturing facility as part of a long-term commitment to onshore mRNA vaccine production for respiratory diseases. This initiative will create a multitude of highly skilled jobs and foster collaboration with academic and NHS partners across the UK. We're looking for global experts eager to join us in this endeavor, contributing to a future where access to life-saving vaccines is a reality for all.
As a Sr. Manager, Quality Assurance (GLP/GCLP and CSV) at Moderna, you'll be at the forefront of ensuring quality and compliance within our dynamic and innovative environment. This role requires a deep understanding of global Health Authority Regulations, including US FDA 21 CFR Parts 58 and 11, GLP/GCLP international regulations, and Computerized System Validation (CSV) standards. You'll be instrumental in overseeing Moderna Biomarker laboratory activities, ensuring the integrity and quality of bioanalytical analysis, and providing vital Quality support to validation activities and audits of computerized systems.
Your key responsibilities will be:
Actively participating in strategic initiatives requiring GLP and CSV quality support.
Developing and guiding administration programs to monitor and promote quality and performance operations related to CSV projects and studies.
Planning, conducting, and reporting on internal, in-process, study, and process audits to ensure GCLP compliance.
Leading internal and vendor computer system audits, managing audit CAPAs, and supporting regulatory inspections.
Your responsibilities will also include:
Fostering a culture of quality within Moderna and its R&D efforts.
Providing business support, process improvements, and inspection support as necessary.
Engaging with regulatory agencies and corporate partners during inspections and audits.
Contributing to the continuous development of Moderna’s quality culture.
The key Moderna Mindsets you’ll need to succeed in the role:
Behave like owners: Taking initiative and displaying a sense of ownership over projects and outcomes.
Act with dynamic range: Skillfully balancing strategic thinking with hands-on execution, adaptable to changing environments and challenges.
Here’s What You’ll Need (Minimum Qualifications)
BS/BA, MS or PhD
A minimum of 10, 8, 6 years’ experience, respectively, in Biotech, Pharma or Clinical Research Organization.
Here’s What You’ll Bring to the Table (Preferred Qualifications)
Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for GLP/GCLP (understanding of regulatory guidelines for other countries a plus).
Practical knowledge of GLP/GCLP related audits activities and business standards.
Bioanalytical technology, including but not limited to LIMS, PCR, plate reader, and mass spectroscopy proficiency is highly desired.
Expertise with business office applications, word processing and spreadsheets.
Demonstrated knowledge and/or prior experience in Quality Assurance.
Outstanding communication skills (verbal and written)
Ability to manage multiple projects in a fast-paced environment.
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Ability to make decisions that are guided by policies, procedures, and business plan; receives guidance and oversight from manager.
Relies on experience and judgment to plan and accomplish goals.
Excellent organizational skills and keen attention to detail.
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras!
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
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.
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 make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com . (EEO/AAP Employer) #LI-NS1
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