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Quality System Manager

2 mesi fa


Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno
Job Description

Job Summary:

Thermo Fisher Scientific Inc. is seeking a Quality System Manager to lead and shape a world-class quality system in a regulated industry. The successful candidate will have the opportunity to coordinate and support the quality system through process design and control strategies.

Main Responsibilities:

  • Develop and implement a robust quality regime and framework that supports effective change control, documentation, and training processes.
  • 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.

Technical Skills:

  • 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).

Professional Experience:

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

Foreign Languages:

  • Fluency in English.

Personality Traits:

  • Leadership skills.
  • Problem-solving abilities.
  • Strong decision-making skills.
  • Excellent communication, negotiation, and influence skills.

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.
  • Managing relationships with individuals involved in the project.