Regional Quality Director

1 day ago

Dublin, Dublin City, Ireland beBeeDirector Full time €90,000 - €120,000

Job Title: Regional Quality Director

Overview

We are seeking an experienced and skilled Director of Quality to lead our regional quality operations in Europe.

  • This role will be responsible for ensuring ongoing compliance with GxP regulations across the EU region.

The ideal candidate will have a strong understanding of EU regulatory requirements and a proven track record of operating in a dynamic, cross-functional environment.

Key Responsibilities:
  • Quality Systems Management: Establish, implement, and manage quality systems to ensure compliance with EU and global GxP regulations (GMP, GDP, GCP).
  • Commercial Launch Preparation: Lead quality strategy and execution for commercial launch preparation in the EU region.
  • Regional Quality Lead: Serve as the primary European Quality lead, coordinating with cross-functional global teams including Regulatory Affairs, Manufacturing, Supply Chain, and Clinical Operations.
  • Vendor Oversight: Support qualification and oversight of third-party manufacturers, distributors, and service providers.
  • Cross-Functional Collaboration: Collaborate closely with global QA/QC teams to align systems, processes, and compliance expectations.
Requirements & Qualifications:
  • Experience: Minimum 8 years of progressive experience in Quality Assurance within the pharmaceutical or biotechnology industry.
  • Leadership: Proven leadership experience in a GxP-regulated environment, with a strong understanding of EU regulatory requirements.
  • Communication: Exceptional communication and collaboration skills, with the ability to operate as a strategic liaison between regional and global teams.
  • Education: Bachelor's or Master's degree in life sciences or a related field; advanced degrees or quality certifications preferred.

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