Sr. Manager, Country Quality, Taiwan and Hong Kong

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 is solidifying its presence in Taiwan, a region known for its robust biotech and technology sectors. Our Taiwan office will concentrate on commercial activities, delivering our innovative mRNA products to the Taiwanese market. We're inviting professionals who are eager to drive significant advancements in global health through our cutting-edge mRNA technology.

Reporting to the Director, Country Quality Head– South Korea and Japan, the Country Quality Senior Manager will be responsible for providing Quality Assurance oversight and supporting both external suppliers and internal functions. You will ensure compliance with internal policies, procedures, and specifications, as well as with locally applicable regulatory requirements. This role involves supporting compliance of warehousing and supply chain activities in Taiwan, ensuring adherence to Moderna and regulatory requirements. You will act as the primary contact for local authorities, managing documentation related to importation, distribution, and supply, and coordinating with both internal and external networks to handle deviations, complaints, CAPA, and changes. Additionally, you will play a vital role in integrating Moderna’s innovative technology platform as the company continues to embrace automation and digital technology across all operations.

Here’s What You’ll Do:

Your key responsibilities will be:

• Acting as the local Qualified Person and Country Responsible Person, ensuring compliance with GDP in accordance with market regulatory requirements.

• Implementing and maintaining a quality management system.

• Managing authorized activities with a focus on accuracy and quality of records.

• Coordinating and promptly performing recall operations for medicinal products.

• Addressing and effectively resolving relevant customer complaints.

• Approving suppliers, customers, and any subcontracted activities impacting GDP.

• Performing self-inspections at regular intervals and ensuring corrective measures are in place.

• Keeping appropriate records of delegated duties and making decisions on the final disposition of returned, rejected, or falsified products.

• Approving returns to saleable stock and ensuring adherence to national legislative requirements on certain products.

Your responsibilities will also include:

• Supporting the delivery of Moderna’s products in/from Taiwan, ensuring compliance with Good Importation/Distribution/Supply practices (GDP, GSP).

• Overseeing national lot release testing activities, reviewing summary protocols, and supporting product release as per international/local regulations.

• Serving as the point of contact for local regulatory authorities and facilitating effective communication with internal/external experts.

• Ensuring QA presence at Third Parties in Taiwan to monitor adherence to approved policies, SOPs, quality agreements, and regulations.

• Providing QA oversight to ensure compliance with quality agreements and overall GDP/GSP for Moderna’s products.

• Supporting and contributing to quality investigations of deviations and complaints, and developing CAPA (corrective and preventive actions).

• Reviewing the Annual Product Quality Reviews (APQRs) as required by local regulations.

• Ensuring timely documentation, notification, escalation, and resolution of risks or issues within the scope.

• Collaborating with manufacturing, distribution, and testing contract facility personnel, as well as internal SMEs in MS&T, QC, QA Systems and Compliance, QA Disposition, and Supply Chain to support ongoing operations and resolve issues.

• Supporting the Hong Kong affiliate from a country quality perspective as applicable.

The key Moderna Mindsets you’ll need to succeed in the role:

• Prioritize the platform: You will be at the forefront of ensuring that Moderna's platform is at the core of all quality-related activities. This mindset will drive you to integrate new digital and automation technologies to maintain the highest standards in supply chain management.

• Act with urgency: Given the dynamic and fast-paced environment, your ability to swiftly and efficiently address quality concerns will be critical. This mindset ensures that you stay ahead of challenges, making timely decisions that have a direct impact on the success of Moderna's mission in Taiwan and beyond.

This position requires approximately 10% business travel.

Here’s What You’ll Bring to the Table

• Education: Bachelor’s degree in Sciences or Pharmacy.

• Experience: 7+ years’ experience of Quality management of supply chain (including importation and distribution) for pharmaceutical industry in Taiwan, vaccines/biopharmaceutical experience preferred.

• Specific Certifications or Training: Pharmacist preferred.

• Other Quantifiable Preference: 

  • 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 Taiwanese (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.

  • Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations (specify GMP, GLP, GCP, GVP or other applicable standards)

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.

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 [email protected].

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