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Details

Quality Director


Reference:BCAQSF-245637 Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: €100000+
May be suitable for: QA Director, QA Manager, Quality Director

Our client, a manufacturing facility in Dublin, are seeking a Quality Director to manage a large Quality department with 90 reports. The top-line responsibilities for this role are:
• Leading the site Quality Departments, namely (QA (including Regulatory Compliance), QP and QC to meet both site and global strategic goals, site KPI’s and objectives
• Acting as primary contact for regulatory authorities and subject matter expert with respect to all relevant Health Authorities but primarily the Health Products Regulatory Agency.

Responsibilities:
• Hosting of all Regulatory Authority inspections and corporate audits and ensuring the site is inspection-ready.
• Primary contact for all matters relating to defect reporting to the Health Products Regulatory Agency (HPRA).
• Identification of key quality trends to the management team to ensure proactive maintenance of high quality standards and status of compliance.
• To ensure that the site Quality Systems and third-party contractors meet current Quality and Regulatory Standards.
• To coordinate product recall activities locally, with the HPRA and aligned to the global quality policy.
• Ensure that all drug products are manufactured and tested to the requirements of GMP and provide leadership and support to the Quality team to ensure and that any deviations from procedures/instructions and/or abnormal events are investigated and documented and suitable corrective/preventative actions are taken.
• Overall responsibility for the handling and storage of Controlled Drugs in accordance with relevant procedures, ensuring product security at all times.
• To contribute to the site strategic plan.
• Manage the Quality Department within budget.
• To manage the Quality Department to meet both site and global strategic goals, key performance indicators and Quality Department Plan.
• To ensure the independence of the Quality Department in decisions on Quality related matters.
• To organise and resource the Quality Department to meet current and future business demands.
• Source and implement Quality Management System tools to support improvements in Business Processes.
• Provide leadership to the Quality Department with regard to annual individual objective setting and measurement, creation and management of development plans, career planning guidance and coaching
• Proactively ensure that all Health, Safety and Environmental responsibilities are carried out according to HSE Regulations and Plans.
• Any other duties as requested by the Managing Director and Senior Director Regional EU Quality.

Requirements:
• Educated to degree level and/or 15 years plus experience in pharmaceutical QA/QP/QC/Manufacturing roles.
• 15 years plus in front line experience in pharmaceutical drug product QA/QP/QC/Manufacturing position in a wide portfolio of dosage forms (preferably to include oral solid dose) and hold QP qualification recognised by HPRA



Contact Brian Christensen on 01 6854747 or submit your CV to brian.c@lifescience.ie for immediate consideration
If you would like further Information you can contact the recruiter directly:

Brian Christensen | Tel: +353 (0) 1 685 4747