Associate Director-Quality Assurance
Outline of Role:
As members of the quality management team the Associate Director Quality Assurance is a key leader in the cross functional support of the manufacturing , warehouse and/or quality control operations. The Associate Director QA is 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 across their area.
Key Responsibilities:
- Be an active member of management team understanding the business and their role to ensure the business objectives are met
- Supervision and coaching of their 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.
- Ensures that 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.
- Provides 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 network.
- Specifically, during the startup phase of the Limerick site (2023 to 2025) this role will be expected to be a collaborative, inclusive, energetic leader and support the broader Limerick team to:
- Build the organisation with the necessary capability, capacity and culture to operate this facility to the highest standards of excellence
- Develop and implement the systems and processed needed to run the site, leveraging existing 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.
Pre Requisites
- Proven capability within a GMP Manufacturing environment.
- Previous leadership experience through existing or previous roles.
Educational/Experience Requirements
- Bachelor of Science, Engineering, QP or equivalent Quality Management Qualifications
- Preferred over 6 years GMP Manufacturing experience and at least 1 year experience in leading a manufacturing support team in a Pharmaceutical/Bio-pharmaceutical setting.
Additional Skills/Preferences:
- Strong written and oral communication skills
- Ability to work independently, self-sufficiently and pro-actively in the performance of work duties.
- Ability to resolve conflict, and promote good decision making among team members
Key Attributes : (These will be what are used to assess the candidates)
- Business Knowledge : High performance in delivery of their work. Looks at better, simpler ways , takes initiative and will run proactively with actions. Demonstrated self-management, prioritisation and organisational skills.
- Learning agility and Curiosity : High learning agility and flexibility and ability to deal with ambiguity and uncertainty. Demonstrated ability to identify and prioritize problems, develop and implement solutions.
- Positive Influence : Demonstrated ability to address issues as they arise and take action. Trusted in the team to follow through on actions. Is interested in own performance and seeks feedback to improve.
- Relationship Builder : Demonstrated ability to establish and maintain key relationships across all levels in the organisation.
- Ability to lead people : Demonstrated ability to lead and motivate in a team environment. Demonstrated ability to influence peers and across functions.
- Communication : Demonstrated strong communication skills, written and oral in 1:1 and group situations.
- Decision Making : Demonstrated ability to be decisive and make well informed decisions for the benefit of the team. Demonstrated ability to collate required information and ask the appropriate questions of peers to get to the best solution.
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