Product Quality Strategist

hace 6 días


Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo

Company Overview

At Novartis Farmacéutica, we are driven by our purpose to reimagine medicine and improve lives. Our vision is to become the most valued and trusted medicines company in the world.

About the Role

The Product Quality Lead will be responsible for ensuring end-to-end quality stewardship of assigned biologics products across multiple sites, from late phase development to discontinuation. This role requires a strong understanding of cGMP regulations and guidelines, as well as excellent analytical and communication skills.

Key Responsibilities

  • Accountable for end-to-end product quality strategy across the global network and drive continual improvement through product and process lifecycle management.
  • Provide expert quality guidance and technical support for implementation of quality guidelines, regulations, standards, processes, and strategy.
  • Maintain global quality oversight and oversee regulatory filing activities, including product registration and variation management.
  • Act as global quality lead in product-related escalations, recalls, and BPDR handling.

Requirements

  • 5+ years of experience in an operational GxP area in a Manufacturing/Development or Quality.
  • Solid knowledge in biology/chemistry, pharmacy, and biotechnology.
  • Thorough knowledge and expertise in cGMP and applicable guidelines.
  • Excellent analytical and communication skills.

Estimated Salary: $120,000 - $180,000 per year



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