Job Overview
Astellas is dedicated to developing innovative treatments that positively impact patients' lives. To achieve this goal, we are focused on tackling complex health challenges and prioritizing patient-centricity in all our activities.
The Role
We are seeking a strategic Quality Assurance leader to oversee the Quality Assurance function at our Ireland Tralee Plant. This individual will be responsible for ensuring all qualification activities meet regulatory requirements, establishing and maintaining a site Quality Management System, reviewing and approving validation documentation, and engaging with regulatory agencies.
Key Responsibilities:
* Strategic QA Direction: Provide visionary quality leadership 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 to build a high-performing and motivated workforce.
* Regulatory Compliance & Readiness: Oversee all regulatory interactions and inspections, ensure audit preparedness, and maintain compliance with all applicable regulations to support timely commercial readiness and license maintenance.
Requirements:
To succeed in this role, you will need a science-based degree with extensive managerial experience in a cGMP compliance environment. Experience of QA management in an aseptic manufacturing plant is desired. Further qualifications are also desirable.