Overview

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In this role you will own stability management across late development to commercial lifecycle, ensuring product quality for a portfolio. You will contribute to the Stability CoE and work with PQI/PQO/PQL to support regulatory readiness and continuous improvement. You'll act as a Stability SME, mentor colleagues, and engage cross-functionally to address escalations and data needs. This position offers a path to influence product quality at scale within a mission-driven healthcare innovator.

Retribuzione / Benefits

- annual premio with target
- vacation days
- parential leave (minimum 12 weeks)
- bereavement leave
- well-being reimbursement
- insurance plans

Responsabilità
- End-to-end stability management accountability from late-stage development to commercial lifecycle
- Lead product quality activities with a specialist focus on stability
- Support PQI/PQO/PQL and ensure smooth Stability CoE operations
- Be the expert in stability management for assigned products




- Operate independently with minimal supervision in the PQS role
- Support departmental goals and cross-functional meetings
- Serve as PQS for highly complex product families and high-value L&G; initiatives
- Identify opportunities for process and quality improvements
- Mentor less seasoned CoE members
- Handle stability-related escalations and regulatory filings with stability data
- Prepare stability protocols and reports; manage excursions and change control for assigned products

Requisiti fondamentali
- 6-8 years xkiyazw of industry experience
- Bachelor's Degree
- Ability to work in a team environment
- Ability to manage individual assignments with minimal guidance
- Ability to read and interpret SOPs, work instructions, protocols
- Clear knowledge of stability-related regulations
- Proficient with Microsoft Office and web-based collaboration tools
- Business alignment
- Coaching
- Communication
- Stability management
- Regulatory filings with stability data
- SOPs and protocols

📌 Product Quality Specialist (Latina)
🏢 Johnson u0026 Johnson
📍 Latina