Description
Quality Control Lead
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need, Learn more at
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Location and Working Environment
* This position is 100% onsite in Tralee, Ireland.
Purpose & Scope
* Oversee daily operations of QC teams including microbiology, biochemistry, and general QC.
* Ensure materials, in‑process samples, drug substance, and sterile drug product meet quality standards.
* Lead sterility assurance, environmental monitoring, microbiological oversight, and data integrity.
* Provide leadership across QC labs including method lifecycle, stability, contamination control, and inspection readiness.
Role And Responsibilities
* Lead, coach, and develop QC teams, building future leaders and high‑performing culture.
* Deliver QC objectives, stable supply, multi‑project execution, and continuous improvement.
* Ensure full compliance with GMP/GDP, GLP, safety and environmental regulations; maintain audit readiness.
* Support strategic planning, new product/technology introductions, and global alignment.
* Build best‑practice QC organisation, strengthen global partnerships, and support site leadership.
* Lead technology adoption, critical knowledge management, crisis readiness, and business continuity.
Required Qualifications
* Bachelor's degree (or equivalent) in a Scientific discipline or extensive relevant experience.
Preferred Qualifications
* Extensive experience in similar QC leadership roles; cGMP start‑up experience advantageous.
* Strong validation and technical competence; proven capability in cross‑functional project work.
* Excellent organisational and communication skills; adaptable, collaborative, and improvement‑focused.
What awaits you at Astellas?
* Global collaboration.
* Real‑world patient impact.
* Relentless innovation.
* A culture of growth.
Our Organizational Values and Behaviors
* Impact
* Innovation
* Integrity
* One Astellas
* Accountability
* Courage
* Sense of Urgency
* Outcome Focus
Benefits
Astellas offers a comprehensive and competitive benefits package. Learn more at
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter anything suspicious, report it promptly to LinkedIn Help.