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Quality System Director

2 mesi fa


Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

**Lead and Shape a World-Class Quality System**

Thermo Fisher Scientific Inc. is seeking a highly skilled professional to join our team in Italy. As the Quality System Manager, you will have the opportunity to coordinate and support the Quality System through process design and control strategies.

**Key Responsibilities:**

  • Develop and implement a robust quality regime and framework that supports effective change control, documentation, and training.
  • Sponsor and drive continuous improvement programs related to quality system processes.
  • Lead the competence area during customer and regulatory agency inspections.

**Requirements:**

  • Bachelor's Degree in Pharmacy or Pharmaceutical Chemistry.
  • Solid knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP).
  • Experience with 21CFR Part 11 and Annex 11.
  • Previous supervision or management experience.
  • Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).

**Ideal Candidate:**

  • At least 7 years of experience in a regulated industry, or 5 years with related technical knowledge.
  • Project Management, Supervision, or Management experience.
  • Fluency in English.

**Competencies:**

  • Strong communication skills.
  • Ability to make quality decisions by calculating risks and understanding their impacts.
  • Collaboration and proactivity.
  • Leadership focused on achieving outcomes.
  • Project management skills, with the ability to work on multiple projects simultaneously.