Our client a leading healthcare company in the South East of Ireland are currently recruiting for a Quality Director
Provide Quality leadership and direction to the site to meet all relevant regulatory requirements and company priorities
Lead the site Quality team (Approx 100 people)
Function as a member of the site Senior Leadership Team
Job Description:
Ensure the sites Quality Control and Quality Assurance teams are organized to deliver efficient, compliant release and support activities
Ensure full QMS deployment as appropriate
Ensure effective Risk Management is in place and in use
Ensure the sites audit programmes are effective
Ensure site changes are managed via the correct process
Ensure the site Quality Council process is effective
Champion the reduction of nRFT issues and waste
Help build process understanding and optimisation
To develop and maintain effective interfaces with above site support functions and appropriate Regulatory Agencies
Ensure successful uptake of GMS Quality initiatives (e.g QMS deployment, PUCC, Stability SS, Quality IT projects, etc)
Education / Professional Qualifications:
Degree or equivalent in a relevant science subject
Understanding of Medicinal and Medical Device regulations and manufacturing to meet European, US & Japanese requirements
Experience as a Quality Leader in a cost-challenged environment
Training and experience in implementing Lean Sigma / OE principles
Preferred
Be an EU Qualified person