Senior Quality Systems Director

14 ore fa


Monza, Lombardia, Italia Mygwork A tempo pieno
About the Role

We are seeking an experienced Senior Quality Systems Director to lead and shape our world-class quality system in Monza, Italy.

Job Description

The successful candidate will have the opportunity to coordinate and support the Quality System through process design and control strategies, building a robust quality regime and framework that supports effective change control, documentation, training, product quality review, continuous process verification, vendor management, and quality agreements. The role will also involve sponsoring and driving continuous improvement programs related to these topics.

Main Responsibilities
  • Develop and implement quality policies and procedures that align with regulatory requirements.
  • Coordinate and conduct internal audits and assessments to ensure compliance with quality standards.
  • Lead the competence area during customer and regulatory agency inspections.
  • Identify and implement opportunities for process improvements and efficiency gains.
Requirements

To excel in this role, you will need:

  • 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).
  • 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.
What We Offer

In return, we offer a competitive salary of €80,000 - €110,000 per annum, depending on experience, plus a range of benefits, including:

  • A comprehensive health insurance plan.
  • A generous pension scheme.
  • 25 days' annual leave, plus bank holidays.
  • A flexible working arrangement.
  • Ongoing training and development opportunities.

This is an exciting opportunity to join our ambitious team at Thermo Fisher Scientific Inc. and contribute to our mission of enabling our customers to make the world healthier, cleaner, and safer.



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