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 Operations Lead is responsible for overseeing manufacturing operations ensuring a safe, efficient, and compliant environment. This role involves managing a team of staff and outsourced service providers, coordinating activities, and implementing policies and procedures to enhance operational efficiency. The role is also responsible for maintaining regulatory compliance for all relevant systems, GMP and Non-GMP. The
Operations lead will also oversee all aspects of continuous improvement.
The position will be responsible for managing, coaching and developing all aspects of these functions with input and local accountability for strategy, forward planning, safety, quality, delivery, cost and service performance.
Responsibilities:
- Leadership & People Development: Provide strong leadership to the Operations Team, fostering a culture of accountability, engagement, and cross-functional collaboration. Develop future leaders and high-performing teams through coaching and targeted development.
- Organizational Excellence: Build a best-practice infrastructure, promoting innovation, quality, psychological safety, and alignment with company values. Attract and retain talent while supporting graduate development and global collaboration.
- Performance & Continuous Improvement: Drive departmental objectives, stable supply, and effective project management. Champion continuous improvement, challenge existing practices, and set ambitious performance targets aligned with KPIs.
- Compliance & Governance: Ensure full adherence to corporate policies, GMP, GDP, safety, and environmental regulations. Maintain audit readiness and produce timely reporting in line with governance standards.
- Strategic Alignment & Growth: Contribute to site and global strategic planning, lead high-impact projects, anticipate future trends, and develop teams and capabilities that align with long-term business objectives.
- Technology, Change & Business Continuity: Lead change initiatives, manage technology and asset upgrades, and ensure business continuity through proactive risk management and crisis readiness.
Education:
- Third level qualification in an Engineering or Science discipline, or extensive related proven experience in the required areas, or equivalent.
Preferred knowledge/experience:
- Third level qualification in an Engineering or Science discipline, or extensive related proven experience in the required areas.
- Previous leadership experience an advantage.
- Knowledge of GMP and validation of systems essential.
- Proven experience working on Aseptic fill finish team an advantage.
- A good knowledge of Health and Safety Systems and Environmental Control Systems is an advantage.
- Proven experience participating in regulatory inspections
Additional information:
This is a 23 month fixed term contract position.
Position is based in Tralee – Ireland.
This position requires you to be 100% on site / in the office.
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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