About Astellas
At Astellas we are making treatments that matter to people.
Description
Head of QA - Tralee
The Opportunity
The role is responsible for the Quality Assurance function of the Astellas Ireland Tralee Plant.
This includes providing leadership and strategic direction related to the qualification of the facility to enable commercial aseptic manufacturing capability.
Responsibilities will include ensuring that all qualification activities (supplier, instrument, manufacturing equipment, storage areas etc) are performed in a manner that meet regulatory requirements, establishment and maintenance of a site Quality Management System, review and approval of all validation documentation and engagement with regulatory agencies.
Establishment of a culture of quality is also a key part of the role.
The main purpose is to ensure all activities are completed to a level of compliance that will ultimately deliver a valid manufacturing authorisation for the plant so that global supply of key Astellas products can be achieved.
The role holder will also support other functions of the Plant as required.
Responsibilities
Strategic Quality Leadership: Accountable for the Quality Assurance (QA) function at AICL Tralee Plant, providing 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 to build a high-performing and motivated workforce.
Regulatory Compliance & Readiness: Oversee all regulatory interactions and inspections (HPRA, FDA, EMA, etc.), ensure audit preparedness, and maintain compliance with all applicable regulations to support timely commercial readiness and license maintenance.
Cross-functional Collaboration & Support: Partner with the Head of Plant, senior leadership, and cross-functional stakeholders to embed quality requirements in strategic planning and operations; act as key QA contact for internal and external stakeholders.
External Communications & Quality Culture: Lead communications with regulators, industry peers, and partners to foster transparency and collaboration; drive a culture of quality and compliance throughout the organization.
Education
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.
Additional Information
Position is based in Tralee
This position is 100% on-site
Willingness to undertake international travel
What We Offer
A challenging and diversified job in an international setting.
Opportunity and support for continuous development.
Inspiring work climate.
The position is based in Tralee - Ireland
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.
Seniority level
Director
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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