Quality Assurance Compliance Specialist

About Astellas

Astellas is a global life sciences corporation dedicated to transforming innovative science into valuable therapies for patients. The company focuses on developing treatments in areas such as oncology, ophthalmology, urology, immunology, and women’s health. Their research and development efforts aim to create pioneering healthcare solutions for diseases with significant unmet medical needs.

Position Overview

This role is based entirely onsite at Astellas’ Tralee aseptic manufacturing plant in County Kerry, Ireland. The Quality Assurance Compliance specialist will be part of the Quality Assurance team, responsible for ongoing development, deployment, and upkeep of GxP (Good Practice) compliance standards. The role includes leading the coordination and management of the site's Quality Management System (QMS), including electronic QMS (eQMS) metrics in alignment with ICH Q10 and Tier 4 requirements, ensuring robust compliance and quality oversight.

Key Duties and Responsibilities

• Support and manage the site’s QMS and eQMS to guarantee compliance with Good Practice (GxP) requirements covering governance, metrics, risk management, and continual improvement initiatives.
• Review, authorize, and manage quality documentation including validation records, change controls, and investigations via platforms such as TrackWise and Vault, enforcing timely completion following SOPs and regulatory guidelines.
• Plan and coordinate internal audits, regulatory inspections, customer and corporate audits; manage corrective and preventive actions (CAPA), and support inspection readiness along with audit response and closure activities.
• Drive quality programs with a focus on continuous improvement initiatives such as Product Quality Reviews, nurturing a strong culture of quality, managing complaints, and maintaining risk registers to enhance operational excellence.
• Collaborate with internal departments including Validation, Engineering, Manufacturing, Facilities, Document/Data Management, Quality Control, suppliers, and global quality teams to ensure comprehensive compliance and quality communication.
• Lead efforts to cultivate a strong quality culture, mentor QA colleagues, and support the overall development of quality capabilities across the site.

Required Qualifications and Experience

• A relevant scientific degree combined with proven experience operating within a cGMP compliance environment.
• Prior experience within a Quality Assurance function, specifically supporting aseptic manufacturing operations, is essential.
• Demonstrated ability to support regulatory inspections, customer audits, and contribute to cross-functional quality systems development, management, and maintenance.

Company Culture and Benefits

• Opportunity to connect and collaborate globally with leaders in the life sciences industry.
• Chance to contribute meaningfully to transformative therapies impacting patient lives worldwide.
• Work environment encouraging innovation at the cutting edge of scientific advancements.
• A culture emphasizing professional growth, supporting employee development and aspirations.

Organizational Values

• Impact
• Innovation
• Integrity
• One Astellas
• Accountability
• Courage
• Sense of Urgency
• Outcome Focus

Additional Information

Astellas is committed to equal employment opportunities regardless of race, color, religion, sex, national origin, disability status, protected veteran status, or other protected characteristics. Applicants should be mindful of recruitment scams; official communications come exclusively from verified Astellas profiles or company emails.