Associate Director Quality Assurance

at  ScientificJobsie

Reference:SCAAYL541350
Location: Limerick
Limerick City
Qualification:Degree
Experience:5-7 Years
Job Type:Permanent
Salary:Not Disclosed
May be suitable for: QA Director, QA Manager, QA Specialist, QA Supervisor, Qualified Person, Quality Manager, Quality Specialist

REQUIREMENTS

• Bachelor of Science, Engineering, QP or equivalent Quality Management Qualifications
• Preferred > 6 years GMP Manufacturing experience and at least 1 year experience in leading a manufacturing support team in a Pharmaceutical/Bio-pharmaceutical setting
• Proven capability within a GMP Manufacturing environment
• Bio experience is required
• Previous leadership experience through existing or previous roles
  For more information, contact Sinéad Cullen on +353879500821 or [email protected]

• Active member of management team understanding the business and their role to ensure the business objectives are met
• Supervise and coach of the QA team members including completing performance reviews and development planning, to ensure continued growth of technical depth and capability with the team
• Manage training, qualification and performance of the team. Set job expectations and goals for individuals linked to team/site goals. Communicate appropriately with team members regarding site objectives and team business.
• Ensure adequate resources are in place to support operations, new product introductions, batch disposition and quality system activities and productivity/continuous improvement initiatives in their area of responsibility
• Review and approve specific quality documents consistent with procedural requirements; including, but not limited to, deviations, change controls, procedures, annual product reviews and validation documentation
• Responsible for the escalation of critical quality issues as appropriate to Quality Management consistent with site procedure on Notification to Management
• Provide technical leadership and advice for key Quality issues
• Identify, prioritise, and support the implementation of continuous improvement initiatives, to maintain compliance while striving to meet business and customer needs
• Maintain a continued state of cGMP compliance and readiness for Pre-Approval Inspections (PAIs) and Routine GMP Inspections by regulatory agencies
• Promote continued alignment in Quality assurance business processes in Limerick and across the wider organisation network
• Build the organization with the necessary capability, capacity and culture to operate the new manufacturing facility to the highest standards of excellence
• Develop and implement the systems and processed needed to run the site, leveraging existing company knowledge and practices where necessary, but also incorporating external experiences and learning
• Ensure regulatory compliance and operational excellence by supporting lean principles and a Digitally Native approach
• Support the project team as they deliver the facility to the site team, by providing feedback and support on decisions & strategies etc. Collaborate with them to ensure the right decisions are made to meet project deliverables and longer-term strategic goals for the site