This is a fantastic opportunity to join a growing Irish company as a Quality Manager. The role is based in Galway but would also involve visits tohigh profileMedical Device and Pharmaceutical clients. This is an exciting role for a driven and focused individual to help during a period of growth within the company.

Responsibilities and Duties:

• Lead QA team working closely with the clients to ensure accordance with GMP Quality Management System
• Lead the activities of the Quality Assurance Department including documentation management and activities related to the QMS
• Provide leadership and direction to the Quality and Site Management Teams to ensure business, quality and compliance goals are met
• Provide technical support in the identification of non-compliance’s / deviations from the quality system and implement corrective actions and procedures to prevent re-occurrence
• Investigate customer complaints and implement corrective actions
• Measure & Monitor close out of technical issues, NCR’s, CAPAs, Supplier issues, Hygiene, Documentation on and off site
• Identify areas for improvement & work with teams to strive for a best in industry standard
• Actively participate in quality improvement plans to enhance customer experience
• Ensure Quality KPI’s are achieved and maintained
• Ensure the QMS is implemented, maintained and improved on where necessary
• Monitor and report on Quality performance on a daily, weekly and monthly basis at the relevant forums
• Prepare for, participate in and in some cases, lead customer visits & 3rd party audits
• Give operational direction to the QA group in the execution of their duties
• Coach, develop, train and up skill employees to enhance knowledge of ISO & GMP Standards
• Drive business improvements through management, mentoring and support of the QA Team
• Maintain quality agreements and collaboration with Third Parties both inter-company and externally

• Bsc or equivalent in Lifesciences
• A minimum of 5 years’ experience with 3-5 years of progressively responsible positions
• A broad knowledge of quality and regulated environments and industry regulators
• Ability to manage or co-ordinate high performing teams to achieve desired outcomes
• A capacity to influence across regions and territories to gain acceptance and accountability of multi-site standards
• Experience in management of ISO 9001:2015
• Excellent communication and interpersonal skills and have demonstrated the ability to lead in a previous role
• Strong team building skills with proven abilities in decision making and sound personal judgement
• Organisational and investigation skills critical