Our client is a leading global innovator, manufacturer, and marketer of pharmaceutical products with over fifty years of experience providing science-driven solutions to improve the health, well-being, and productivity of its patients. This organisation has six cutting-edge R&D facilities on four continents that work on an enviable product development pipeline that anticipates the ever-changing needs of the industry as part of their global innovation program. A leader in its field and a business with a long-standing history here in Ireland are currently looking to recruit a Director of Quality Assurance - EU to head up the organisations Quality Operations based here in Ireland.

The Position:

• Provides leadership in developing and directing quality assurance and improvement initiatives for all company and supplier products and ensures ongoing compliance with local, national, and international standards and legislation.
• Promotes and advocates quality achievement and performance improvement across the organization by integrating quality control tools into processes (eg Continuous Improvement) and supporting new product development.
• Perform gap/risk analysis between applicable and current regulatory standards; establish and implement a quality plan to bring the company into regulatory compliance.
• Accomplishes financial objectives by forecasting requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.
• Monitors QA systems and advises executive team on system performance; publishes statistics regarding performance against set goals and makes recommendations.
• Leads the preparation for Health Authority inspections and audits and provides support to their execution and follow-up. Ensures that corrective and preventive actions (CAPAs) are tracked and implemented as committed and ensures timely remediation of any issues related to CAPAs.
• Responsible for ensuring that all product quality complaints are being adequately investigated, trended, & reported and collaborates with department to ensure full customer satisfaction.
• Responsible for final product release to customer.
• Participates as required in the investigations regarding batch discrepancies, non-conformances and out-of-specification events to evaluate impact on product quality and ensure corrective action and non-recurrence. Approves/rejects as required.
• Organizes and hosts facility audits by customers, FDA and Health Canada including responding to corrective actions and /or observations as required.

The person:

• Ten years' relevant experience in a regulated Pharmaceutical industry including Quality Assurance, Quality Control, with 5 years in a leadership role.
• BSc degree in science or related field.
• Knowledge of Analytical Chemistry, cGMP, Quality Systems, Drug Regulatory Affairs, Stability protocols and systems, manufacturing and packaging processes would be beneficial.
• Must possess apparent leadership qualities to be able to comfortably and successfully interface and communicate with all levels internally and externally.

To discover more about this opportunity, apply now or contact Gamy Anbalahan at HRM on +353 1 6321823 for a confidential discussion.