Quality System Manager

at  Thermo Fisher Scientific

JOB DESCRIPTION

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.

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.

Education:

• Bachelor’s Degree in Pharmacy or Pharmaceutical Chemistry

TO EXCEL IN THIS ROLE, YOU WILL NEED:

Education:

• Bachelor’s Degree in Pharmacy or Pharmaceutical Chemistry.

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