Senior Regulatory Specialist for Quality Control and Stability

hace 3 semanas


Madrid, Madrid, España Moderna A tiempo completo

Moderna offers an exciting opportunity to work with a pioneering team in the field of mRNA technology. As a Senior Regulatory Specialist for Quality Control and Stability, you will play a key role in ensuring the quality and safety of our groundbreaking products.About Moderna

Since its founding in 2010, Moderna has been committed to building a leading mRNA technology platform and reimagining how medicines are created and delivered. Our mission is to create a culture of belonging and make a meaningful impact on patients' lives worldwide.

Our company champions innovation and teamwork, fostering a culture rich in direct mentorship and collaboration. With a 70/30 work model, we prioritize in-person interaction to drive excellence and advance our global mission.

Job Description

We are seeking a skilled Senior Regulatory Specialist for Quality Control and Stability to join our team in Madrid, Spain. In this role, you will be responsible for:

  • Ensuring compliance with international guidelines and regulations, including ICH guidelines and GMP requirements

  • Developing and managing stability protocols, reports, and GMP stability study documents

  • Providing technical support for data management, protocol development, and regulatory submissions

  • Collaborating with cross-functional teams to ensure seamless execution of quality control and stability activities

Required Skills and Qualifications

To succeed in this role, you should have:

  • A Bachelor's degree in Chemistry or a related scientific discipline

  • At least 5-7 years of experience in quality control laboratory of a pharmaceutical company

  • Hands-on experience with analytical chemistry testing, including chromatographic techniques (HPLC, UPLC, GC), spectroscopic and spectrometric techniques, physical properties techniques, and titrations

  • Familiarity with stability testing and related activities, such as maintaining stability databases, trending, and statistical analyses

  • Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations

Benefits

As a member of our team, you will enjoy:

  • A competitive salary range of approximately €50,000 - €65,000 per year, based on location and experience

  • Quality healthcare and insurance benefits

  • Lifestyle Spending Accounts to support your well-being

  • Free premium access to fitness, nutrition, and mindfulness classes

  • Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown

Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Apply now to become part of our dynamic team



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