Moderna Therapeutics

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 Basel, the vibrant hub of pharmaceutical innovation in Switzerland, to further our mission of delivering the greatest possible impact to people through mRNA 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 Director, QPPV Compliance/Quality Interface is a pivotal role that supports the EEA/UK QPPV in ensuring comprehensive oversight of all pharmacovigilance (PV) related activities and responsibilities across the Europe region. This position is critical for maintaining the integrity and compliance of our PV system, demanding a high degree of collaboration, quality oversight, and engagement with both internal teams and external stakeholders.

Here's What You’ll Do:

Your key responsibilities will be:

• Providing an independent and objective compliance and quality overview of the pharmacovigilance system across geography to support EEA/UK QPPV oversight.
• Collaborating with Moderna compliance/quality functions for aligned and comprehensive support for R&D Quality and PV Operations.
• Acting as the interface between QPPV office, PV operations, and R&D Quality, particularly in the implementation and follow-up of tracking tools for pharmacovigilance activities.
• Preparing, analyzing, and communicating compliance metrics and significant compliance information to the EEA/UK QPPV.
• Representing the EEA/UK QPPV in vendor oversight, ensuring compliance with Safety Data Exchange Agreement (SDEA), and Pharmacovigilance Agreements (PVA).

Your responsibilities will also include:

• Leading the QPPV office representation in internal and external audit activities related to the PV system.
• Supporting inspection readiness and activities, including preparation and response review.
• Monitoring, interpreting, and validating regulatory legislation/compliance practices and their impact on the PV system.
• Assessing and managing risk to the PV system, including input into the annual audit program.
• Escalating issues impacting the PV system with proposed mitigation strategies.

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

• Dynamic Range: This role demands both strategic oversight and hands-on engagement with detailed operational activities, reflecting a need for versatility and adaptability.
• Prioritize the Platform: Given the pivotal role of pharmacovigilance in ensuring patient safety, prioritizing the integrity and effectiveness of the PV platform is crucial. Your work directly contributes to the resilience and reliability of our pharmacovigilance efforts, impacting patient outcomes across the Europe region.

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

• A Master's degree in life sciences, with equivalent experience considered.
• At least 8-10 years of on-the-job experience in PV compliance/quality role.
• Strong knowledge of the principles of European pharmacovigilance legislation and global pharmacovigilance requirements (EU/local Directives, EU/local regulatory processes, ICH Guidelines)
• Extensive previous experience in PV inspections and audits is required.
• Details oriented with strong analytical, prioritizing, interpersonal, problem-solving, & planning skills
• Ability to identify and implement process and/or application improvements
• Collaborative and curious with ability to work in an environment of rapidly changing priorities and workload; ability to manage multiple activities and assignments.
• Strong verbal and written communication skills
• Fluent in English - both verbal and written

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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)