Global Validation Supervisor

Global Validation Supervisor Location: Ballina, Co. Mayo, Ireland

Department: Quality

Role Summary The Global Validation Supervisor will lead a team of Validation Quality Engineers, overseeing the planning, coordination and execution of equipment, process and test method validation activities. The role supports new product introductions, change control and strategic initiatives, ensuring compliance with the Quality Management System and applicable regulatory requirements within a regulated manufacturing environment.

Key Responsibilities

• Lead, coach and develop a team of Validation Quality Engineers, ensuring delivery of project and compliance objectives.
• Plan and coordinate equipment, process and test method validation activities.
• Review and approve validation documentation, including plans, risk assessments, protocols, reports and deviation records.
• Ensure validation activities comply with internal procedures, regulatory requirements and industry best practices.
• Manage resources, project timelines and competing priorities to meet operational objectives.
• Collaborate with Design Assurance, R&D, Engineering, Manufacturing and Quality teams.
• Support internal audits, regulatory inspections and CAPA activities.
• Drive continuous improvement across validation processes, standard work and compliance practices.
• Apply risk-based decision-making and communicate technical findings effectively to stakeholders at all levels.

Essential Requirements

• Bachelor’s degree in Engineering, Science or a related discipline, or equivalent experience.
• Typically 8–12 years’ experience in validation, quality engineering or a related field within a regulated industry.
• Experience in medical device, pharmaceutical or similarly regulated manufacturing environments.
• Previous experience leading or supervising technical or quality teams.
• Strong organisational, problem-solving and communication skills.
• Ability to manage multiple priorities while maintaining high quality and compliance standards.

Desirable Requirements

• Certified Quality Engineer (CQE) or equivalent qualification.
• Advanced degree in a technical or scientific discipline.
• Working knowledge of ISO 13485, FDA 21 CFR Parts 820 and 11, and other relevant regulatory standards.
• Experience with statistical analysis, validation tools, audits and regulatory inspections.

Key Competencies

• Adaptability: Responds effectively to change and embraces new approaches.
• Customer Focus: Considers customer needs and quality expectations in decision-making.
• Collaboration: Builds strong relationships across teams and functions.
• Accountability: Takes ownership of deliverables and drives results.
• Continuous Improvement: Promotes efficiency, compliance and high-quality standards.