Senior Quality Assurance Manager

6 ore fa


Roma, Lazio, Italia Thermo Fisher Scientific A tempo pieno

At Thermo Fisher Scientific, we're accelerating research and solving complex scientific challenges. Our customers rely on us to make the world healthier, cleaner, and safer. As a Senior Quality Assurance Manager in our Sterile Injectables team, you'll play a crucial role in ensuring the quality of our products and adhering to regulatory requirements.

About the Role

This is a senior leadership position responsible for managing a team that oversees the quality assurance processes for sterile injectable drugs. You'll ensure compliance with cGMP regulations, company quality standards, and site GxP processes. The successful candidate will have extensive experience in similar roles within regulated environments, such as pharmaceuticals or medical devices.

The ideal candidate will possess a strong understanding of global cGMP, pharmaceutical law, quality management systems, and the professional duties of a Qualified Person (QP). They should also have excellent communication skills, mathematical and statistical skills, and experience in quality event management.

Responsibilities
  • Manage a team responsible for quality assurance processes for sterile injectable drugs
  • Ensure compliance with cGMP regulations, company quality standards, and site GxP processes
  • Review and support activities related to product disposition, including batch data, batch records, deviations/investigations, and other quality systems documentation
  • Drive continuous improvement initiatives to enhance quality and efficiency
Requirements
  • Proven experience in similar positions within regulated environments
  • Recognized by Regulatory Authorities to act as Qualified Person (QP) status
  • Minimum Bachelor's degree in a relevant field, such as chemistry, biology, or pharmacy
  • Strong knowledge of GMP regulations, pharmaceutical law, and quality management systems
  • Excellent communication and problem-solving skills
What We Offer

We offer a competitive salary range of $120,000 - $180,000 per year, depending on experience. Additionally, you'll enjoy a comprehensive benefits package, including health insurance, retirement plans, and paid time off. Our company values diversity, equity, and inclusion, and we welcome applications from qualified candidates from all backgrounds.

Join Us

If you're a motivated and experienced leader who shares our passion for quality and innovation, please submit your application. We look forward to hearing from you



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