Product Quality Specialist
Pubblicato il 21-08-2026 - Experteer Italy in Latina
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
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