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

AOP Health is the European pioneer for integrated therapies for rare diseases and in critical care. To enhance our team in Italy we are looking for a:

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.

• 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

• 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)

• 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