Director of Quality Assurance

2 weeks ago

Cork, Cork, Ireland beBeeQualityCompliance Full time

A top-tier medical device organization is seeking an expert in pharmaceutical quality and compliance to join its team as Director of Quality Assurance.

This permanent position involves delivering guidance on quality and regulatory compliance, ensuring that all pharmaceutical products meet strict safety, quality, and legal standards.

  • As a subject matter expert in pharmaceutical quality, you will provide leadership and ensure departmental resources align with business goals and compliance requirements.

  • You will lead audit teams, coordinate with cross-functional departments, and implement corrective actions to address findings.

  • Additionally, you will oversee the Pharmaceutical Quality Management System & Continuous Improvement, ensuring compliance with industry regulations and quality standards.

  • Required skills include a Bachelor's degree in Science or Engineering, 10+ years of experience in pharmaceutical or biotech production, and at least 5 years of managerial or leadership experience in a quality-focused function.

  • Strong knowledge of cGMP, ICH standards, EU GMP Annexes, and FDA/HPRA requirements is also essential.

The ideal candidate will have excellent communication and interpersonal skills, be able to work independently, and possess a strong problem-solving attitude. If you are passionate about pharmaceutical quality and compliance, we encourage you to apply for this exciting opportunity.

Key Responsibilities:

  • Develop and implement quality management systems and processes to ensure compliance with regulatory requirements.

  • Lead audit teams and coordinate with cross-functional departments to address findings and implement corrective actions.

  • Oversee the Pharmaceutical Quality Management System & Continuous Improvement to ensure compliance with industry regulations and quality standards.

  • Collaborate with cross-functional teams to ensure alignment with business goals and compliance requirements.

  • Provide training and support to ensure compliance with regulatory requirements and industry standards.

  • Stay up-to-date with industry developments, regulatory changes, and best practices in pharmaceutical quality and compliance.

Requirements:

  • Bachelor's degree in Science or Engineering (Master's degree or higher is an advantage).

  • 10+ years of experience in pharmaceutical or biotech production with a strong background in Quality Assurance (QA), Quality Control (QC), or Compliance.

  • At least 5 years of managerial or leadership experience in a quality-focused function.

  • Strong knowledge of cGMP, ICH standards, EU GMP Annexes, and FDA/HPRA requirements.

  • Experience as a Qualified Person (QP) is an advantage.

Benefits:

  • Competitive salary and benefits package.

  • Opportunity to work in a dynamic and growing organization.

  • Professional development and growth opportunities.

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