The Role
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through m RNA 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 m RNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.

Moderna is solidifying its footprint in Basel, the vibrant hub of pharmaceutical innovation in Switzerland, to further our mission of delivering the greatest possible impact to people through m RNA medicines. As we grow our international operations and commercial activities in Basel, we invite global talents to join us in this exciting journey of transforming medicine and impacting lives worldwide.
The Sr. Manager, External Quality Control will oversee the planning, organizing, directing, and evaluating of routine external QC activities, including stability and project deliverables of external QC laboratories. This role ensures the safety and reliability of products manufactured in compliance with c GMP requirements. The individual will assist in establishing testing program requirements and support investigations for out-of-specification, deviations, and other non-conforming results. Acting as an interdepartmental liaison, the Sr. Manager will interact with various groups within the organization and external QC contacts within contract manufacturing organizations and testing labs for raw materials, drug substance, and drug product.

Here's What You’ll Do:Your key responsibilities will be:
Developing and implementing an integrated QC oversight strategy for external QC testing networks for clinical and commercial programs.

Ensuring on-time performance for QC testing at contract manufacturing organizations and contract laboratories, covering raw materials, drug substances, and drug products.

Supporting cross-functional project teams in Quality Control-related activities and acting as a liaison with CMOs and contract testing labs.

Following up with CMOs and CTLs on reference standards, reagents, and on-time release and stability testing.

Your responsibilities will also include:
Following all relevant Gx P regulations, guidelines, and company policies to ensure regulatory and internal compliance.

Executing tasks as defined in SOPs and work instructions with precision and adherence to Good Documentation Practices.

Completing mandatory training plans on schedule, adhering to requalification timelines.

Requesting data trending, analysis, and reporting from CMOs and CTLs to support quality oversight.

Developing QC capacity models based on manufacturing demand plans.

Reviewing and approving procedures, protocols, reports, and associated documentation.

Leading complex laboratory investigations to resolution with external testing labs and providing technical assessments for QMS activities, including deviations, investigations, and change controls.

Monitoring and presenting key performance indicators (KPIs) for external QC testing networks.

Interfacing with Health Authorities as needed to address QC testing inquiries.

Managing the external testing QC budget and leading capital equipment requests.

Driving continuous improvement initiatives (Op Ex) within the external QC framework.

The key Moderna Mindsets you’ll need to succeed in the role:
We pursue options in parallel: In the role of Sr. Manager, External Quality Control, you will need to keep multiple QC oversight strategies and collaborations moving simultaneously to ensure all pathways for quality testing meet high standards and timelines.

We act with urgency: Given the impact of each product release and the essential role of quality control in patient safety, you'll act promptly to ensure all QC activities are compliant, effective, and timely.

Here’s What You’ll Bring to the Table:
Education: Master’s degree in relevant scientific discipline

Experience: 10 years of experience in the pharmaceutical/biotech industry within Quality Control

Specific Certifications or Training: None

Other Quantifiable Preference:
Strong understanding of c GMP, regulatory requirements, and industry standards.

Excellent, management, analytical, and problem-solving skills.

Proficiency with digital quality systems (e.g., LIMS, QMS, CDS).

Strong written and oral communication skills, and ability to work effectively in a cross-functional matrix environment.

Detail-oriented, organized, and capable of managing multiple projects in a fast-paced environment.

Technical writing and ability to present results.

Strategic Vision and Influence Capability

Experience leading continuous improvement projects in testing laboratories.

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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