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Head, Tralee Qa

4 weeks ago

Tralee, Ireland Astellas Pharma Full time

Overview
Description: Head of QA - Tralee
About Astellas: 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.
We have developed ground-breaking, innovative medicines in immunology, oncology and urology.
Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked.
We take a patient-focused approach that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients' lives.
From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.
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 include ensuring that all qualification activities (supplier, instrument, manufacturing equipment, storage areas, etc.) are performed in a manner that meets 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 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.
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