In this role, you will own stability management across Late Stage to commercialization for a product portfolio. You’ll support PQI/PQO and contribute to the Stability CoE, ensuring high-quality stability data, protocols, and reports. You collaborate with global teams to address stability questions, audits, and regulatory expectations. The position offers exposure to end-to-end product quality in a global, customer-centered organization known for healthcare innovation.
- annual premio
- parental leave for 12 weeks
- insurance plans
- Stability POC for product families (API and Drug Product)
- Oversee stability sample management
- Author/oversee stability protocols and reports per global SOPs
- Support audits and filings related to stability
- Manage stability lifecycle and related questions with PQI/PQO and partners
- Assist with temperature excursions, change controls, stability notifications and escalations
- Maintain stability statements for assigned products




- Collaborate with Stability Labs to resolve questions timely
- Active member of Stability CoE supporting departmental goals and process improvements
- Bachelor's degree in a technical/scientific field (Pharmacy, Chemistry, Biology, Biochemistry, Engineering)
- Minimum 6 years of relevant experience
- Minimum 4 years in pharmaceutical/biotechnology/medical device industry
- Experience in API and drug product stability and related business implications
- Understanding of quality systems (change control, CAPA, event handling) and risk management
- Knowledge of GMP regulatory guidelines and global regulatory requirements
- Ability to work independently and in teams; strong communication skills
- Willingness to travel up to 5–10% domestic/international

📌 Product Quality Specialist (Latina)
🏢 Experteer Italy
📍 Latina