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Quality & Compliance Specialist (Italy) (f/m/d)

Full-time Pisa

In this role, you will ensure compliance with regulatory and corporate requirements while supporting our local Quality Management System. You will work in close collaboration with cross-functional teams to maintain the highest standards of quality and compliance.

This position is limited to a minimum of one year as maternity leave cover.

What Your Day To Day Will Look Like

  • Support the Quality Management System (QMS/eQMS) in compliance with GxP and corporate procedures.
  • Draft, update, and maintain quality documentation and SOPs.
  • Provide training (onboarding and recurring) on quality and compliance processes.
  • Manage incidents, complaints, CAPAs, deviations, and returns.
  • Ensure compliance in daily operations, including documentation and archiving (paper and digital).
  • Conduct supplier and customer qualification.
  • Coordinate internal and external audits, including follow-up and CAPA plans.
  • Monitor compliance with GDP, GVP, GDocP, Legislative Decree 219/2006, AIFA, EMA, and other regulations.
  • Support corporate compliance policies (anti-bribery, transparency, HCP interactions, scientific information, drug traceability).
  • Handle transparency reporting (Sunshine Act) and approval workflows for promotional materials, events, donations, and sponsorships

Your Qualifications and Experience

  • Degree in Pharmaceutical Chemistry and Technology, Pharmacy, Biology, or related field.
  • Minimum of 3 years of professional experience in Quality Assurance or Compliance in the pharmaceutical or healthcare sector.
  • Solid knowledge of GxP standards (GDP, GVP, GDocP) and understanding of EU/Italian regulatory frameworks (AIFA, EMA, Legislative Decree 219/2006)
  • Hands-on experience with Quality Management Systems (QMS/eQMS) and document control processes
  • Proven ability to manage audits, CAPAs, deviations, and complaints
  • Strong communication and organizational skills with the ability to work independently
  • Fluency in English and Italian (spoken and written)

Our Offer

  • An open corporate culture with the opportunity to contribute your own ideas
  • Structured onboarding and training opportunities to support your professional growth. 
  • Being part of a successful team who drives the business forward
  • Competitive bonus scheme, additional benefits and employee events.

  • Opportunities for personal and professional development within an international environment

  • A role with high impact and responsibility in a growing, innovative company

If you would like to work as a team player in an international environment and can identify with our values "Agile, Ambitious, Aligned, Accountable and Appreciative", then: Take this CHANCE and
APPLY NOW

Please submit your application exclusively via the application link.

Introduction

Main Benefits

Bonus
Homeoffice
Flexible working hours
Initial and continuing education
Employee events

Your Contact


Kathrin Breuer, BA, MA
Senior Associate Talent Aquisition

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