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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Associate Director Quality Assurance


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

Associate Director Quality Assurance
Our client, a global biotech, are currently recruiting for anAssociate Director Quality Assurance to join their team on a permanent basis. As Associate Director Quality Assurance, you will lead the cross functional support of the manufacturing , warehouse and/or quality control operations. You will be responsible for QA business processes including support of GMP and GLP compliance, regulatory inspection readiness, Quality Plan and continuous improvement projects and will provide leadership and direction to the QA team.

Responsibilities:

  • 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
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]