Qualified Person, Uk

Moderna

Harwell, United Kingdom
**
Qualified person (qp) responsibilities
Batch release certification
Eu gmp and mhra guidance
** Moderna is seeking a Qualified Person (QP) for their Harwell, UK site to ensure compliance with regulatory standards for mRNA-based drug product releases. The role requires extensive experience in quality assurance within the biotechnology or pharmaceutical sectors, focusing on maintaining high standards of manufacturing and product safety. **

Job Summary

  • As a Qualified Person (QP), reporting to the Site Quality Head, you will play a critical role in ensuring the release of Moderna’s innovative mRNA-based drug products aligns with the strictest regulatory standards.
  • Your key responsibilities will be acting as the named Qualified Person (QP) on Moderna’s site licence(s) and certifying and authorising batch releases in full compliance with The Human Medicines Regulations 2012, EU GMP (Annex 16, and where applicable, Annex 13), and MHRA guidance.
  • At Moderna, we believe that when you feel your best, you can do your best work. That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

Matching Summary

Match Score: 75

** Moderna is seeking a Qualified Person (QP) for their Harwell, UK site to ensure compliance with regulatory standards for mRNA-based drug product releases. The role requires extensive experience in quality assurance within the biotechnology or pharmaceutical sectors, focusing on maintaining high standards of manufacturing and product safety. **

Skills & Requirements

Must-have

  • Qualified Person (QP) responsibilities
  • batch release certification
  • EU GMP and MHRA guidance
  • biologics and sterile products
  • Pharmaceutical Quality System (PQS)

Nice-to-have

  • driving innovation and adaptability
  • digital and data-driven decision making
  • lean principles for process improvement
  • risk-based mindset for decision making

Key Requirements

  • Life Science degree and/or postgraduate qualification
  • minimum 10 years’ experience in quality roles
  • biotechnology and/or pharmaceutical industry experience
  • Eligibility to act as a Qualified Person (QP)
  • experience in GMP-regulated environments
  • expert knowledge of Pharmaceutical Quality Management Systems
  • experience hosting and participating in regulatory inspections

Work Rights

Not specified

Tailored Resume

Cover Letter