National QSHE Director Dublin, Ireland | Weitere Stellenangebote | Vollzeit | req121831 Elevate Healthcare Logistics Standards with a Leading Global Provider We are looking for an accomplished National QSHE Manager to lead and enhance our Quality, Safety, Health, and Environmental (QSHE) standards within the healthcare and life sciences sector.
This role is crucial in ensuring regulatory compliance, patient safety, and operational excellence across warehousing and transport activities for pharmaceuticals, medical devices, and healthcare products.
Your Role You will be responsible for developing and maintaining a robust Quality Assurance Program, overseeing Operational Qualification (OQ) and Performance Qualification (PQ) studies, and ensuring compliance with GDP (Good Distribution Practice), GMP (Good Manufacturing Practice), ISO 13485, and ISO 9001.
With a focus on risk management, CAPA processes, and continuous improvement, you will be the key point of contact for regulatory authorities, healthcare customers, and internal stakeholders, driving best-in-class quality and compliance standards across our healthcare logistics operations.
Your Responsibilities Develop, enhance, and maintain the company's QualityAssurance Program to meet best-in-class healthcare and life sciences standards.
Ensure compliance with GDP, GMP, ISO 13485, ISO 9001, andother relevant healthcare regulations across warehousing and transportoperations.
Lead OQ (Operational Qualification) and PQ (PerformanceQualification) studies for healthcare logistics, ensuring full compliance withindustry standards and customer requirements.
Manage the QMS (Quality Management System) in alignment withhealthcare regulatory policies, ensuring full documentation, audit readiness,and risk mitigation.
Develop and implement training programs to enhance awarenessof healthcare quality standards, regulatory compliance, and patient safety.
Act as the company's healthcare compliance representative,managing customer audits, regulatory inspections, and quality-relatedinquiries.
Champion the CAPA process, ensuring timely and effectiveresolution of non-conformities, deviations, and compliance issues related tohealthcare logistics.
Use continuous improvement tools to drive qualityenhancements, patient safety measures, and risk mitigation strategies.
Maintain strong collaboration with customers and regulatoryauthorities, ensuring transparency, compliance, and high standards inhealthcare logistics.
Provide regular reports and insights to senior leadership,ensuring proactive decision-making in healthcare quality management.
Your Skills and Experiences QSHE qualification or degree in life sciences, healthcare,pharmaceuticals, or a related field.
Experience in healthcare logistics, pharmaceuticaldistribution, or medical device supply chains.
Deep understanding of GDP, GMP, ISO 13485, ISO 9001, andhealthcare regulatory requireme nts.
Internal and/or external auditing experience in healthcare,pharmaceuticals, or medical supply chains.
Strong analytical skills with an exceptional eye for detailin compliance monitoring and reporting.
Proven ability to manage CAPA processes and drive continuousimprovement in healthcare logistics.
Excellent communication and stakeholder management skills,with experience working with regulatory authorities and healthcare customers.
Self-motivated, proactive, and able to work independently ina dynamic, fast-paced healthcare environment.
Good Reasons to Join We offer an employee friendly and casual environment for you to become a skilled quality logistics professional in a challenging and fast developing company with a competitive salary and opportunities for further development within Kuehne+Nagel.