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QA Director
4 weeks ago
GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & have multiple projects that we support and are currently looking for experienced professionals to join us for this role. Role title - QA Director - CQV, Pharma & Data Centers Location:Ireland & Europe Region Reports to:CEO/Managing Director Type:Full-time Job Summary: We are seeking an experienced QA Director to lead our Quality Assurance function, ensuring compliance with ISO quality standards, pharma QA regulations, and CQV/CxA best practices. The successful candidate will oversee the development, implementation, and maintenance of quality management systems across our engineering services, data centers, and pharmaceuticalQA services. Responsibilities: Develop, implement, and maintain comprehensive CQV programs and procedures for pharmaceutical manufacturing and data center construction. Ensure compliance with FDA regulations (cGMP), ISO standards (ISO 9001, ISO 27001), GAMP 5, and other relevant industry standards and regulations. Lead and manage the QA and CQV teams, including hiring, training, performance evaluation, and professional development. Oversee the development and execution of commissioning, qualification, and validation protocols (IQ, OQ, PQ). Plan and conduct internal and external audits to assess compliance with quality systems and regulatory requirements, focusing on CQV processes. Manage document control, including the creation, review, approval, and revision of SOPs, protocols, reports, and CQV documentation. Oversee change control processes, ensuring changes are properly evaluated, documented, and approved, particularly those affecting validated systems. Handle investigations of deviations, non-conformances, and customer complaints related to CQV activities, and implement corrective and preventive actions (CAPA). Develop and monitor quality metrics and key performance indicators (KPIs) for CQV activities to identify trends and areas for improvement. Provide QA and CQV support during validation activities, including equipment qualification, process validation, software validation, and data integrity assessments. Management of project commissioning for Data Centre project and ensure implementation of the MEP deliverables on the project Collaborate with engineering, manufacturing, IT, and other departments to ensure quality and CQV are integrated into all aspects of operations. Serve as the primary point of contact for regulatory inspections and customer audits related to CQV. Stay current with industry trends, regulatory changes, and best practices in quality assurance and CQV. Qualifications: Bachelor's degree in Engineering Minimum of 10 years of experience in Quality Assurance, with at least 5 years in a leadership focused on CQV. Extensive experience in the pharmaceutical industry, including knowledge of cGMP, FDA regulations, and validation processes. Experience in data center construction and commissioning Strong knowledge of CQV methodologies, quality management systems, auditing techniques, and statistical analysis. Certifications such as ASQ Certified Quality Auditor (CQA), Certified Quality Manager (CQM), or certifications related to CQV are a plus. Skills: Senior level quality experience leading, coaching, mentoring, and developing digital teams. Proven record of identifying and developing strategic quality engineering talent. A passion for Quality Engineering practices and proven record of implementing such practices. Agile leadership experience. Committed and inspirational people leader capable of developing others within your knowledge area to accelerate and achieve increased skill proficiency. Strong communication, interpersonal and relationship building skills and the ability to engage and influence at all levels of the organization. Bring a track record of continuous improvement and success in fostering agile ways of working. CQV (Commissioning, Qualification, Validation) Regulatory Compliance (cGMP, FDA, ISO) Quality Management Systems Auditing Documentation Control Change Management Intellectually curious and models a culture of continuous learning, mentoring, and coaching. To start the process click the Continue to Application or Login/Register to apply button below.
