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Details

Operational Quality Manager


Reference:SGARUX-872374 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: BD Manager, Quality Manager

Operational Quality Manager

Life Science Recruitment are sourcing an experienced Quality Manager for are client who are a leading Irish pharmaceutical distribution organization. The successful candidate will have prior experience working within a Quality function and have the necessary skills to develop, implement and maintain a complex Quality Management System. The role will report to the Group Quality Director and will work closely with the Operations department while being the link between the Quality department and key stakeholders in driving overall improvement and ensuring regulatory compliance.

Roles & Responsibilities

• Maintain Group Manufacturing Importation Authorisation & Wholesaler’s Authorisation
• The Responsible Person will be responsible for the compliant management of and the operations of the Group to cGDP (current Good Distribution Practice) & cGMP (current Good Manufacturing Practice).
• Perform all activities in compliance with Group safety standards and SOPs
• Liaise and lead regulatory inspection activities and with pharmaceutical inspection teams.
• Lead the Quality team of employees in the achievement of organisational goals.
• Project manage and schedule key projects and initiatives insuring timely execution and goal achievement.
• Implement and insures compliance to the quality requirements per the site and Group quality system.
• Develop staff on new quality initiatives and assist in the understanding and rollout of quality initiatives across the department/site.
• Ensure development and maintenance of Regulatory Operations standards and procedures in accordance with all applicable Regulatory regulations, guidance, and specifications.
• Identifies regulatory system enhancement needs or technical issues and works closely with systems and technical support staff to identify, develop, and implement solutions.
• Analyse audit results and make recommendations to management on areas that may require additional staff training, improved documentation or process improvement in order to remain compliant with regulatory standards
• Effectively manage large amounts of information and documentation.
• Review requirements to provide feedback on completeness, evaluation and other risk areas that could impact quality compliance.
• Contribute to the development of high-quality systems by ensuring functionality meets documented specifications, quality requirements and organisational goals.
• Lead issue triage and resolution meetings with internal & external departments.
• Build strong relationships with business and diverse stakeholders and champion continuous improvement initiatives across the Group.
• Design, prepare, distribute and maintain weekly & monthly reports/KPIs summarising information regarding all of the above
• Participating in continuing own and team professional development in order to maintain awareness in current and new regulations and ensuring new regulations are implemented.
• Other projects as assigned by Group Quality Director

Skills & Qualifications

• 3 to 5 years of work experience in a regulated industry (GDP/GMP)
• Must have proven ability to lead a diverse team of people.
• Excellent communication skills and the ability to work well with people at all levels are essential.
• Must have strong organisational, analytical, problem solving, influencing and management skills.
• Project management experience is a plus
• Knowledge and experience with software including word processing, spreadsheets and statistical analysis
• Ability to work in a fast paced team environment, effective decision-making and problem solving skills
• Proven time management and prioritisation skills focusing on urgent and overlapping deadlines
• Strong organisational skills, attention to detail and proven accuracy with record keeping
• Ability to work independently
• Bachelor’s degree in science/engineering related field preferred
Additional Qualities
• Strong leader with ability to mentor, develop and motivate teams
• Positive can-do attitude with a focus on action not debate
• Results orientated
• Pursues a standard of excellence, relentlessly measuring and chasing to ensure targets met
• Resolves conflict constructively and works well under pressure





If you would like further Information you can contact the recruiter directly:





Simon Gillivan | Tel: +353 (0) 1 507 9258 Email: simon.gillivan@lifescience.ie