Manager, Quality Assurance for Quality Control

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 footprint in Madrid, a city known for its rich scientific heritage. This facility, the largest such center outside the United States, exemplifies our commitment to solidifying our manufacturing network and advancing our promising mRNA product portfolio. We're looking for talents who can contribute to our innovative research and development efforts.

In this role, you will provide quality oversight and guidance to Quality Control (QC) and Analytical Science and Technology (AST) across Moderna's global network. This individual is a key member of the Quality Assurance for Quality Control team, building a culture of quality in our GxP and GMP laboratories. The Manager of QA for QC supports global laboratories, including those in Norwood, Madrid, Resilience sites, and external testing labs.

Here’s What You’ll Do

Your key responsibilities will be:

• Ensure the quality policy and objectives are understood, implemented, and maintained at all levels within the QC and AST laboratories.

• Ensure QC and AST quality systems, processes, specifications, methods, and SOPs are appropriately designed and compliant with global pharmacopoeia and regulatory requirements.

• Author, review, and approve QC/AST SOPs, reports, policies, Annual Product Quality Reviews (APQR), and trend reports to ensure cGMP compliance.

• Provide oversight during technical development phases to ensure activities comply with internal quality standards.

• Evaluate and monitor the integration of quality assurance in QC and AST processes, ensuring alignment with program phases.

• Identify risks and gaps in quality and GMP process/systems and communicate them effectively.

Your responsibilities will also include:

• Review and approve deviations, change controls, work orders, laboratory investigations, SOPs, and commissioning/qualification documents for QC equipment.

• Ensure personnel follow Good Documentation Practices and Data Integrity requirements.

• Support audits and inspections with compliant and accurate data, documentation, and records.

• Review and approve facility alarms and facility work order requests.

• Additional duties as may be assigned from time to time.

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

• We behave like owners: In this role, you will have ownership of quality systems and processes, ensuring that they exceed compliance standards and meet Moderna's strategic objectives.

• We push past possible: Your innovative mindset and commitment to high standards will help drive the continuous improvement of QC and AST systems, supporting the global mission of delivering groundbreaking mRNA medicines.

Here’s What You’ll Need (Basic Qualifications)

• Education: Bachelor’s Degree in Biology, Microbiology, Chemistry, Biochemistry, or related field.

• Experience: 5-8 years of experience in the pharmaceutical/biotech industry within Quality Assurance or Quality Control.

• Specific Certifications or Training: None

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Management/supervisory experience in a cGMP organization.

• Experience in analytical or microbiological method validation and/or medical device QA.

• Familiarity with environmental monitoring, microbiological testing, or chemistry analytical techniques.

• Knowledge of FDA, EU, ICH guidelines, and relevant regulations.

• Proficiency in Microsoft Office tools and statistical programs/software.

• Experience with risk management and digital solutions for quality systems. 

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

• This role is expected to be in office 70% of the time with flexibility to work from home up to 30%.

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].

#LI-NS1

-