Director of Quality & Operations
š Director of Quality & Operations
š Location: Dungarvan, Ireland
š 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.
š 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.
š 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.
š 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.
FAQs
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