**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
Are you looking for a unique opportunity to lead and shape a world-class quality system? Thermo Fisher Scientific Inc. is seeking a Quality System Manager to join our exceptional team in Monza, Province of Monza and Brianza, Italy.
As the Quality System Manager, you will have the opportunity to coordinate and support the Quality System through process design and control strategies. Your main responsibilities will include:
- Building a robust quality regime and a framework that supports an effective approach to Change Control, Documentation and Training, Product Quality Review, Continuous Process Verification, Vendor Management, and Quality Agreement.
- Sponsoring and driving continuous improvement programs related to the above topics.
- Leading the competence area during customer and regulatory agency inspections.
**To excel in this role, you will need**:
**Education**:
- 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.