Manager, Dublin Plant QA

4 weeks ago

Dublin Pike, Ireland Astellas Pharma Full time

Overview Manager, Dublin Plant QA — At Astellas we are making treatments that matter to people. We are tackling the toughest health challenges putting the patient at the heart of every move we make. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword – it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. The Opportunity: As Manager QA, Dublin, you will provide value add Quality Assurance input and support for QA related issues at AICL Dublin Plant covering operational functions (manufacturing operations, facilities engineering etc.) to ensure product produced is safe, effective and of the required quality and in compliance with regulatory requirements and commitments. In addition, you will also provide support for quality assurance related issues to AICL Trading Party GDP activities ensuring compliance to regulatory requirements.
Key Responsibilities Support the Quality Management System (QMS) ensuring compliance with cGMP and corporate standards.
Act as Deputy Responsible Person (RP) for the AICL Trading Party under EU GDP and Irish legislation. Ensure GDP compliance, including supplier/customer qualification, recall readiness, and documentation accuracy etc.
Oversee batch release activities, including review and approval of non-conformance and CAPA records.
Foster a culture of quality and data integrity across the site through your daily activities and training.
Ensure proper systems for quality risk management, deviation handling, CAPA, and change control.
Manage vendor qualification, quality agreements, and oversight of outsourced activities.
Plan and lead audits, inspections, and self-inspections; host regulatory and customer audits.
Support regulatory submissions, CMC activities, and responses to regulatory inquiries.
Lead resolution of critical quality issues, including customer complaints and escalations.
Implement and improve QMS processes, collaborating with global teams and supporting Operational Excellence.
Support development and training of QA personnel and promote cross-functional collaboration.
Monitor and report quality metrics (KPIs) to ensure performance oversight and continuous improvement.
Ensure all activities comply with safety, environmental, and ISO14001/ISO45001 standards.
Education Level 8 Degree in Science, Engineering, or equivalent.
Preferred Knowledge/Skills & Experience Experience in a GMP environment.
Proven leadership skills.
Experience with lean/operational excellence.
Experience with Quality Management Systems applications.
Additional Information This is a permanent, full-time position.
Position is based on-site in Dublin.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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