Job Description:
The Senior Quality Assurance Manager will lead the Quality Assurance function at our Ireland Tralee Plant. This includes providing strategic direction for the qualification of the facility to enable commercial aseptic manufacturing capability and ensuring all activities meet regulatory requirements.
This role involves establishing a culture of quality, managing the QA team, and overseeing regulatory interactions and inspections.
Key Responsibilities:
* Strategic Quality Leadership: Provide strategic QA direction across all operational areas to ensure product safety, effectiveness, quality, and compliance with global regulatory standards.
* End-to-End Quality Oversight: Ensure product quality from raw material receipt to product release, managing all QA systems including validations, change control, customer complaints, regulatory submissions, and Quality Management Systems (QMS).
* People & Team Management: Lead and develop the QA team through performance management, training, coaching, engagement, succession planning, and fair labor budgeting.
* Regulatory Compliance & Readiness: Oversee all regulatory interactions and inspections and maintain compliance with all applicable regulations.
* Cross-functional Collaboration & Support: Partner with senior leadership and cross-functional stakeholders to embed quality requirements in strategic planning and operations.
Requirements:
* Science-based degree with extensive managerial experience in a cGMP compliance environment.
* Experience of QA management in an aseptic manufacturing plant desired.
* Further qualifications desirable.
This position is based in Tralee, Ireland. The ideal candidate will have a strong track record in QA management and be willing to undertake international travel.