Associate Director of Quality
DESCRIPTION
Applications are invited for the opportunity of Associate Director, Quality Control. Reporting to the Director of Quality Control the successful candidate will manage all aspects of the Quality Control function (Commercial and Development) including Raw Material, Packaging, In-Process and Finished Product testing and associated support activities for a Pharmaceutical company whose technologies and discoveries have contributed to the development of medicines that have helped shape the treatment landscape, and form the basis for their current investigational products in a range of disease areas.
KEY RESPONSIBILITIES
• Management of daily/weekly laboratory issues while ensuring schedule and target adherence in conjunction with the Planning Department.
• Ensure optimisation of laboratory resources and operations in accordance with cGMP, regulatory and business requirements.
• Management of employee relations, change, policy implementation, motivation, performance, discipline, appraisals, target setting, communications, occupational health & safety, training, etc.
• Play appropriate role in the development, operation and evaluation of GMP training programmes, and ensure that training is carried out in accordance with the training plan/specific departmental training needs.
• Assist in ensuring that current compliance issues and trends, both internal and site-wide, are critically evaluated and appropriate corrective and preventive actions are provided.
• Management of process improvements, technical developments and opportunity in order to increase operational efficiencies and maximise output.
• Ensuring compliance with regulatory requirements and GMP/quality standards, audit preparation and management of audits as it relates to area of responsibility.
• Management of special projects as appropriate.
• Manage the transfer of new project technologies and analytical methods.
• Continuously improve analytical methodologies and laboratory systems to ensure continuing cGMP compliance and improve departmental cost efficiencies.
• Represent Quality Control department at internal and external meetings with other departments, customers and suppliers and at company audits involving customers and regulatory bodies.
• Provide input for Budget and CAPEX Preparation and manage budget for area of responsibility.
REQUIREMENTS
• Third level qualification in a science discipline, preferably BSc in a chemistry subject.
• Minimum 10 years Pharma technical expertise & relevant leadership/people management experience in a quality environment.
• Specialist knowledge of pharmaceutical operations within the regulated industry.
• Experience of FDA/HPRA regulated site.
• Excellent knowledge of laboratory practices and cGMP applicable to a pharmaceutical environment.
• Logical problem-solving skills and experience in management of complex investigations.
• Excellent people management skills and ability to collaborate effectively cross functionally and with customers.
• Knowledge and experience in Lean Labs principles is a distinct advantage
• Excellent written and oral communication skills.
• Proven track record in your current role is essential
• Responds positively to changing circumstances and priorities.