Quality , Science, Pharmaceutical & Food

Associate Director Quality Systems

  • Full Time
  • Remote
  • Limerick
  • 41822720

Summary:
You will be responsible to provide broad Quality Assurance expertise and leadership as required with an understanding of local regulatory as well as global expectations.
The successful candidate will be the Site Owner of a number of Quality Systems and responsible for identifying potential risks within the systems and communicating/collaborating with other functions.

Essential Duties and Responsibilities include, but are not limited to, the following
• Ensure the Quality Systems adhere to tight internal standard and including the Local / International regulatory bodies.
• Identify leading practices and recommend improvements to continuously improve compliance profile.
• Identify Trends in recent regulatory inspections and translate this to recommendations to enhance readiness.
• Work closely with other compliance teams to close gaps, improve practices and maintain compliance.
• Define and implement quality standards, systems and metrics for maintaining regulatory compliance for operations.
• Interface with Customers/partner quality organisations as required.
• Participates on internal committees/teams as required.
• Provides advice and direction to other company departments on quality issues.
• Provide support during inspections and audits.

Education and Experience:
• Honours Degree BS/BA in Life sciences or B. Eng. in Mechanical or Biomedical engineering (or equivalent), Master’s degree a plus
• Min 8+ years of relevant progressive experience in QA within the Pharma / Biopharma Industry and some experience working with Global Regulatory Agencies.
• Proven experience leading teams in achieving company goals.

For more information please contact Sean on 0214297900 or Sean.Barron@peglobal.net 

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