We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

This role requires a strong focus on QA leadership in the design, installation, and qualification of facility, equipment, utility, and process systems, with particular emphasis on Validation Oversight.

Key Responsibilities:

• Provide QA leadership during facility design, and layout
• Provide overall quality direction for processes and procedures associated with project
• Lead QA review and approval of URS, DS, QRAEs, and IQ/OQ/PQ protocols and reports.
• Act as the Quality point of contact and decision-maker during validation execution activities, ensuring all activities comply with regulatory and company standards.
• Ensure Computerised System Validation (CSV) meets regulatory and data integrity standards.
• Ensure validation documentation is robust, traceable, and inspection-ready.
• Drive risk assessments and mitigation strategies for new equipment and processes.
• Provide QA oversight for Change Controls, CAPAs, and Deviation Investigations.
• Ensure all activities align with Amgen’s safety standards, SOPs, and regulatory expectations.
• Support a safe working environment by adhering to all environmental health and safety practices, rules, and regulations.

• University degree in a Science or Engineering-related discipline.
• Minimum of 10 years of relevant experience in the pharmaceutical or biotechnology industry.
• Proven expertise in facility startup and Quality Oversight of Validation activities.
• Experience with change control, non-conformance resolution, and CAPA implementation.
• Excellent organizational, communication, and collaboration skills.
• Ability to work independently with minimal supervision and operate effectively across functional boundaries.
• Familiarity with Quality by Design (QbD).
• Proficiency in statistical analysis tools (e.g., Minitab, JMP) is a plus.