Senior Manager, Inspection Management
ModernaHighlight
Summary
About the Role
About You
- BS/BA, MS or PhD with a minimum of 10, 8, or 6 years of experience in Biotech, Pharma, or Clinical Research Organization.
- Knowledge of FDA, EU, ICH GCP guidelines and international GxP regulations.
- Experience with inspection coordination and logistical planning for regulatory authority inspections.
- Experience in Regulatory Intelligence and developing responses to inspection findings.
- Strong analytical, problem-solving, and decision-making skills.
- Ability to manage multiple projects in a fast-paced environment.
Benefits
- Best-in-class healthcare coverage and voluntary benefit programs.
- Holistic approach to well-being with access to fitness and mental health support.
- Family planning benefits including fertility and adoption support.
- Generous paid time off including vacation and sabbatical.
- Savings and investment opportunities.
Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines. Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. This Moderna page is not the appropriate place to report adverse events (side-effects) for any products. If you are or someone you know is experiencing a side effect, please reach out to your healthcare professional. Moderna is continuously monitoring the safety of its products. We encourage you to report any side effects directly to us at 1‑866‑MODERNA (1‑866‑663‑3762).