Director of Quality

DIRECTOR OF QUALITY required for our client based in Limerick. An excellent opportunity for a senior candidate to establish their own processes and team within this multinational biotech company.  Contact: lorraine.walsh@eflexes.com for a confidential update on this position.  

  Duties include: 

• Drive the design, analysis and oversight of global, phase-appropriate Quality Management System (QMS) Structure to ensure compliance to applicable regulations, including U.S. and EU and EMEA
• Provide technical expertise and assist in the development and maintenance of raw material specifications.
• Adapt departmental plans and priorities to address resource and operational challenges
• Hire, develop, and retain department staff (including contract staff) to create a high-performing team that exemplifies best quality practices.
• Provide leadership, direction, and mentorship across all levels of the organisation to assure quality assurance and validation strategies are known and implemented.
• Develop strong relationships with external consultants/contractors as necessary.
• Partner closely with the Regulatory Affairs and Supply Chain teams to ensure that quality is designed throughout in order to ensure registration success and long - term scalability.
• Drive, promote and embed a culture of ethics, integrity and continuous improvement that will focus on delivering efficiencies.
• Persuasion and negotiation skills and the ability to interact successfully and partner with senior management within and outside of Quality
• Anticipates and interpret customer needs to identify solutions

• Develop a budget, manage expenditures, and oversee issue resolution
• Self-motivated and highly driven leader; works as a team player and/or independently
• Ensure an organisational structure capable of adapting to changing business needs and champion the company value
• Up to 25% Domestic and international travel may be required

Basic Qualifications:

• Doctorate degree and 6 years of Quality and/or Operations experience Or
• Master’s degree and 10 years of Quality and/or Operations experience Or
• Bachelor’s degree and 12 years of Quality and/or Operations experience And
• 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs