Our Clare based pharma client is now recruiting Director of Quality to join their organisation. This is an excellent opportunity for Quality Manager with required experience in pharma to take their career to the next level!
Provide leadership, direction and expertise with regards quality, including; quality assurance, quality control, regulatory affairs, and product release (QP) activities at the site.
• As a member of the site leadership team (SLT), contribute to the management and success of the business.
• Lead and direct the quality function and provide a strategic vision for quality at the site.
• Develop and maintain effective quality management systems in accordance with quality standards, regulation and corporate quality systems.
• Maintain cGMP (GxP) compliance in all activities in conjunction with site management and operations.
• Report to operations and facility management on a routine basis, including goals, achievements, gaps and opportunity for improvements.
• Develop close and effective relationships with departmental directors, managers and supervisors to support effective quality standards are met, and to ensure quality is built into all processes and products at the site.
• Support / lead inspections by third parties (e.g. inspections by regulatory bodies, customers, and internal inspections).
• Prepare and monitor annual departmental budgets.
• Review and approval of SOPs and other quality related documents.
• Review effectiveness of the quality systems, lead and support a culture of continuous improvement / operational excellence.
• Develop close and effective relationships with corporate, other sites and third Parties through effective communication to maximize business compliance and performance.
• Develop department resources and expertise to maximise return to the organisation from improvement projects and contribute to the company’s ongoing success.
• Establish department and team member objectives and goals which support site objectives and goals, and strategy.
• Manage department performance at both departmental and individual levels.
• Support the development of team members.
• Ensure compliance with GMP and Safety Health Environment (SHE) policies at all times.
• Ensure unsafe acts or non-compliant acts or environmental conditions are proactively identified and resolved.
• Any other reasonable job related duties that may be required from time to time.
• Degree in chemistry or another relevant discipline or relevant experience in the pharmaceutical industry.
• Excellent organisational and time management skills (is organised and can prioritise demands).
• Strong communication skills: listening, written, verbal, presentation and interpersonal (ability to communicate effectively at all levels and with varying personalities).
• High attention to detail, high level of accuracy in all aspects of the position.
• Creative, strong problem solving, critical thinking and analytical abilities.
• Drives and supports change and continuous improvement culture.
• Self-starter, positive attitude and motivated by the role and can motivate others.
• Good work ethic and ability to meet assigned deadlines.
• Committed to the Company, flexible and willingness to adapt with business requirements.
• Works to the highest professional, ethical and moral standards.
• Exercises discretion and confidentiality at all times.
• 10+ years’ experience working in a quality function within a multinational pharmaceutical regulated environment.
• 5+ years’ quality management experience.
• Proven continuous improvement / operational excellence experience.
• Ideally six sigma accreditation green belt or Black belt.
• Ideally has project management experience and certification.
• Experience in leading regulatory inspections is essential.
• Extensive knowledge of quality systems and cGMP.
• Regulatory requirements for APIs and Pharmaceutical products.
• Application of six sigma, quality risk