Director of Quality & Operations

🌟 Director of Quality & Operations

📍 Location: Dungarvan, Ireland
🕒 Full-time | Senior Leadership Role

Are you a strategic leader with a passion for quality and operational excellence in the pharmaceutical or medical device industry? We're seeking a dynamic Director of Quality & Operations to lead a high-performing team at a global manufacturing site. This is a pivotal role that combines oversight of Quality Assurance, Quality Control, and Manufacturing Operations to ensure compliance, efficiency, and continuous improvement.

🔍 Key Responsibilities

• Lead and integrate Quality and Operations functions to ensure seamless product delivery and regulatory compliance.
• Oversee the implementation and maintenance of cGMP-compliant quality systems and operational excellence programs.
• Act as a key advisor to the Site Leadership Team on quality, compliance, and operational strategy.
• Ensure readiness for regulatory inspections and internal audits; manage CAPAs and risk mitigation plans.
• Drive a culture of continuous improvement, right-first-time execution, and cross-functional collaboration.
• Monitor and improve KPIs across quality and operations, using data-driven decision-making.
• Lead strategic initiatives including sourcing, capacity expansion, and technology transfers.
• Develop and mentor a strong leadership pipeline across Quality and Operations teams.
• Manage departmental budgets and resources effectively to meet business goals.

🎓 Qualifications & Experience

• Bachelor's or Master's degree in Chemistry, Pharmacy, Biology, Engineering, or related field (PhD preferred).
• 10+ years of leadership experience in pharmaceutical or medical device manufacturing, with proven success in both Quality and Operations.
• Deep understanding of global regulatory standards (e.g., EU MDR, ISO 13485, US CFR 210/211/820).
• Strong background in quality systems (e.g., HQS), lean manufacturing, and continuous improvement methodologies.
• Exceptional leadership, communication, and stakeholder management skills.

🌐 Why Join Us?

• Be part of a global organization with a strong commitment to innovation, quality, and patient safety.
• Lead a site that manufactures life-enhancing products distributed worldwide.
• Influence strategic decisions and shape the future of manufacturing excellence.