Associate Director, Global Quality Stability lead

Reporting to the Sr. Director of Global Product Quality, the Associate Director / Director, Global Stability Lead, will be responsible for the oversight of the stability programs for Clinical and Commercial products.

This position as single contributor is expected to work in a highly collaborative and cross-functional team environment (including Technical Development groups) and act as key SME in regulatory filling.

This position will ensure that stability data complies with regulatory requirements and supports product shelf-life claims, as well as continuous improvement of product quality.

Here’s What You’ll Do:

• Oversee and manage the overall stability program for mRNA products and ensure compliance with international regulatory guidelines.
• Provide strategic direction and oversight for the design of stability protocols, including accelerated and long-term stability studies.
• Collaborate with Technical Development, Regulatory Affairs, and Quality teams to ensure alignment on stability requirements for product development and lifecycle management.
• Organize the Stability governance and manage performance.
• Act as key SME on stability sections of regulatory submissions and respond to queries from health authorities.
• Drive continuous improvement initiatives within the stability function and contribute to cross-functional process enhancement projects.
• Support timely investigation and resolution of stability-related deviations and out-of-specification results.
• Lead Global Change control linked to stability.
• Stay abreast of industry trends, regulatory guidance, and best practices in stability management.
• Mobility 10-15%

Here’s What You’ll Bring to the Table:

• Education: Advanced degree in a scientific discipline (MSc or Ph.D. ) with a minimum of 10 years of relevant experience in the pharmaceutical or biotechnology industry.
• Experience: 10 years of experience in the pharmaceutical industries, with 5+ years’ experience leading Quality Control/Stability Labs in a cGMP organization.
• Extensive experience in biopharmaceutical & GMP
• Knowledge in risk management, and quality system requirements.
• Capacity to work in dynamic range from deep dive to establishing big picture.
• Ability to interact effectively with all levels of personnel within the organization.
• Proven ability to lead and manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines.
• Excellent interpersonal skills using a team-oriented approach to project management and problem solving for complex issue resolution in a scientifically sound and understandable way.
• Outstanding communication skills (verbal and written).
• Ability to navigate through ambiguity and rapid growth and adapt to change.
• Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.
• 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 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 [email protected]. (EEO/AAP Employer)

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