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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Associate Director Quality Systems


Reference:SCAXHY-583326 Location: Limerick
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed

Associate Director Quality Systems
Our client, a leading biotech organisation are currently recruiting for an Associate Director Quality Systems to join their team on a permanent basis. As Associate Director Quality Systems you will provide broad Quality Assurance expertise and leadership as required with an understanding of local regulatory as well as global expectations. You 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.

Responsibilities

  • 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

Requirements

  • 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