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 pharmaceutical QA 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.