The Role:
Reporting to the Director, Country Quality Head– South Korea , the Country Quality Sr.Specialist will be responsible for providing QA oversight and support external supplier as well as internal functions to ensure compliance with internal policies, procedures and specifications, and locally applicable regulatory requirements.

The Country Quality Sr.Specialist will support compliance of warehousing and supply chain in South Korea with Moderna and regulatory requirements. The incumbent will coordinate with operations and oversee execution of Moderna’s and external suppliers’ activities in compliance with applicable Good Importation, Good Distribution and Good Supply practices. Acting as primary point of contact for local authorities, he/she will edit, submit, review and/or approve documentation related to importation, distribution, and supply. The incumbent will coordinate with internal/external network for management of Deviations, Complaints, CAPA and Change. The incumbent will be an integral partner to Moderna’s innovative technology platform as we continue to integrate automation and digital technology into everything we do.

This role is a maternity leave cover (12+ months).

Here’s What You’ll Do:
Support delivery of Moderna’s products in/from South Korea in compliance with applicable Good Importation/Distribution/Supply practices (GIP, GDP, GSP).

Edit and submit summary protocols to support release of products as per applicable international/local regulations

Coordinate with Quality Control of national lot release testing and distribution operations, ensuring data and documentation are complete, accurate and submitted in due time to meet Moderna’s commitments

Be the point of contact of local regulatory authorities, coordinating effective and efficient communication with internal/external network of experts

Ensure QA presence at Third Parties in Korea for adherence to approved policies, SOPS, quality agreements, batch records, regulations

Provide QA oversight to ensure compliance with approved quality agreements and overall GIP/GDP/GSP compliance for Moderna’s products.

Support/contribute to quality investigations of deviation and complaints, and to development of CAPA (corrective and preventive actions)

Ensure timely documentation, notification/escalation and resolution risks or issues in scope.

Review and approve documentation related to importation, distribution, and supply, as appropriate

Collaborate with manufacturing, distribution and testing contract facility personnel and internal subject matter experts in Manufacturing, Science and Technology (MS&T), Quality Control (QC), QA Systems and Compliance, QA Disposition, Supply Chain (SC) to support ongoing operational activities and resolve equipment, testing, and process issues.

This role requires approximately 20% national travel.

Here’s What You’ll Bring to the Table:
Bachelor degree, preferably in Sciences, Pharmacy or logistics.

3-6 years’ experience of Quality management of supply chain (including importation and distribution) for pharmaceutical industry in South Korea, vaccines/biopharmaceutical experience preferred.

Working knowledge of relevant international and local regulations and standards/guidelines (good importation practices, good supply practices and good distribution practices).

Experience in third parties’ oversight, hosting/facilitating successful regulatory inspections is a plus.

Experience in cold chain monitoring applied to sterile product supply.

Fluency in English and Korean (spoken and written)

Excellent interpersonal skills and partnership attitude, using a team-oriented approach to ensure timely delivery of plan and resolve problem for complex issue in a scientifically sound and understandable way.

Attention to details, with ability to assess impact and cause/effect relationship in complex situation

Good communication skills (verbal and written) to operational and leadership employee levels, of external partners, suppliers, third parties, and industry organizations.

Ability to analyze, plan and manage multiple priorities in a fast-paced environment.

Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.

Ability to navigate through ambiguity and rapid growth and adapt to change.

A ‘digital first’ and curious mindset that allows you to constantly learn and challenge the status quo.

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 m RNA 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 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. 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 or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment 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 and Adjustments team at leavesandaccommodations@modernatx.com .
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