Head Of QA – Kerry, Fixed term contract
About Astellas
At Astellas we are making treatments that matter to people. We are tackling the toughest health challenges, placing the patient at the heart of everything we do. Through our global vision for Patient Centricity, we integrate the patient experience into our everyday working practices. We have developed ground‑breaking medicines in immunology, oncology and urology, improving and saving the lives of patients worldwide.
Are you driven to make a real difference in the lives of patients?
We are seeking individuals who thrive in dynamic environments, embrace new ideas and are committed to making a meaningful impact.
Location and Working Environment
- This position is 100% onsite in Killorglin, Ireland.
Purpose & Scope
- This role is responsible for establishing and maintaining a robust Quality Assurance system that ensures compliance with global regulatory standards and supports the safe, effective, and consistent production of pharmaceutical products. It oversees all QA activities including audits, documentation, deviation management, and validation oversight. The position exists as a distinct leadership function to embed a strong quality culture across the site and to safeguard patient safety and regulatory integrity.
Role and Responsibilities
- Lead and continuously improve the site Quality Management System (QMS), ensuring compliance with global standards and regulatory requirements (EU GMP, FDA CFR), including document control and governance.
- Drive audit and inspection readiness by leading internal, customer, and regulatory audits, ensuring timely resolution of findings and effective CAPA implementation.
- Oversee deviation, complaint, and quality issue investigations, ensuring robust root cause analysis, trend monitoring, and corrective/preventive actions.
- Ensure GMP compliance through effective training programs, quality culture initiatives, validation oversight, and approval of change controls.
- Provide QA leadership and regulatory support across manufacturing, engineering, regulatory affairs, and global quality teams, including review of submissions and post-approval changes.
- Serve as a key member of the Pharma QA leadership team, leading strategic quality initiatives, business process improvements, and cross-functional collaboration across the organization.
Required Qualifications
- Bachelor’s degree in a science-related discipline (e.g., Pharmacy, Chemistry, Biology) with extensive pharmaceutical Quality Assurance experience and strong knowledge of EU GMP, FDA CFR, and other global regulatory requirements.
- Demonstrated success in leading QA teams, managing regulatory inspections and audits (e.g., HPRA, EMA, FDA), and collaborating effectively with cross-functional and global stakeholders.
- Proficient in English (written and spoken) with experience using electronic quality systems such as TrackWise, LIMS, and Empower.
Preferred Qualifications
- Advanced academic qualifications in Pharmacy, Pharmaceutical Sciences, or a related discipline, with additional expertise in Quality Management, Regulatory Affairs, or Pharmaceutical Technology, and eligibility for Qualified Person (QP) registration under EU Directive 2001/83/EC.
- Broad pharmaceutical manufacturing and regulatory experience, including solid dosage and/or aseptic operations, validation activities, sterile product handling, regulatory inspections, submissions, and post-approval change management.
- Demonstrated leadership in quality transformation, digitalization, and continuous improvement initiatives, with strong experience in quality systems, operational excellence methodologies, and industry engagement.
What awaits you at Astellas?
- Global collaboration and connection with like‑minded life‑science leaders.
- Real‑world patient impact through transformative therapies.
- Relentless innovation at the forefront of scientific advancement.
- A culture of growth that supports your development and ambitions.
Our Organizational Values and Behaviors
- Impact
- Innovation
- Integrity
- One Astellas
- Accountability
- Courage
- Sense of Urgency
- Outcome Focus
Benefits
Learn more at: https://www.astellas.com/en/careers
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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