Senior Director of Quality Assurance

1 day ago

Dublin, Dublin City, Ireland beBeeQuality Full time

Meet the needs of a commercial-stage biopharmaceutical company developing rare disease therapies as they expand to Europe.

Job Overview

This Senior Director role will oversee quality functions, ensuring compliance and quality systems are built and executed on launch strategy.

The position will be hybrid, with 3 days onsite in Dublin, Ireland. Relocators across the EU are welcome.

  • Lead and maintain the European Quality Management System (QMS) in compliance with EU/UK regulatory requirements.
  • Secure and manage necessary WDA and MIA authorizations, upholding GDP and GMP standards.
  • Act as or support the Responsible Person (RP) for wholesale distribution activities.
  • Oversee audits, inspections, deviations, CAPAs, and change control processes across EU operations.
  • Collaborate with regulatory authorities, vendors, and cross-functional teams to ensure product quality and supply chain integrity.
Requirements

A strong background in quality management is required, preferably in biopharma or rare diseases.

Candidates should have at least 10 years of experience in building a European QMS from the ground up.

  • Degree in Life Sciences, Pharmacy, or a related field; advanced degree (Master's/PhD) preferred.
  • Deep knowledge of EU regulatory requirements and quality standards across the product lifecycle.
  • Excellent communication skills and ability to thrive in a fast-paced environment.

We're seeking an expert who can contribute to our team's success.

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