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
- Premio
- 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:
#J-18808-Ljbffr