20988 – Associate Director Quality Systems – Limerick Full Time

Purpose: 

Responsible to provide broad Quality Assurance expertise and leadership as required with an understanding of local regulatory as well as global expectations.

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.

Minimum Qualifications 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 10 years of relevant progressive experience in QA within the Pharma / Biopharma Industry and some experience working with Global Regulatory Agencies.