Quality & Compliance Specialist (limited 1 year) (Italy)

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.

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.

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.

Main Benefits

• Bonus
• Homeoffice
• Company car
• Employee mobile phone
• Flexible working hours
• Laptop
• Initial and continuing education
• Canteen
• Good transport connection
• Employee events
• Meal allowance
• Company doctor
• Parking spot
• Healthmeasures
• Employee discount

Your Contact

Kathrin Breuer, BA, MA

Senior Associate Talent Aquisition

Further information on our website:

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