Product Quality Specialist

1 giorno fa

Roma, Provincia di Roma; Lazio, Italia Johnson & Johnson Tempo pieno

Overview

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 bonus 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 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