Director, Qppv Compliance/quality Interface

Il y a 7 mois

Paris, France Moderna Temps plein

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 Paris, the heart of France's thriving biotech industry. Our Paris office focuses on commercial operations, ensuring the delivery of our groundbreaking products to the French market. We're inviting professionals from around the world to join us in our mission of delivering the greatest possible impact to people through mRNA medicines.

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

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
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