Information Technology Quality Assurance Manager

Job Summary:We are in the process of strengthening the Quality Assurance and Compliance team within the Technology business unit and are seeking a highly skilled and motivated IT Quality Manager who will play a critical role in ensuring the quality and compliance of our IT systems. This role provides the right candidate an opportunity to make a real difference in overseeing and improving the quality processes, ensuring continuous improvement, managing the internal and external audit programme, and improving the QMS.Key Responsibilities:Providing training, guidance and support on IT Quality, Quality Management System and compliance to GxP regulations.Maintain the QMS ensuring that quality management policies and procedures adhere to industry standards and governing regulations.Maintain the CAPA management process working with different stakeholders to ensure their timely closure.Monitor key performance indicators (KPIs) for quality assurance.Assist in carrying out the internal audits to assure adherence to the QMS.Carry out supplier qualification audits and re-qualification as part of the supplier audit schedule.Carry out and manage periodic reviews of IT systems and applications.Ensure regulatory compliance of GxP systems by the application industry standard regulations, such as FDA 21 CFR Part 11 and GAMP 5, and ensure that computer systems align with these standards.Qualification of 3rd party software.Qualifications & ExperienceYou should have a strong industry background in Computer Systems Validation and IT Quality gained within the life science industries with an excellent regulatory knowledge.Degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences) and 7+ years of experience in computer systems validation and/or IT Quality Management.Strong knowledge of regulatory requirements and industry guidance in the areas of GvP, FDA 21 CFR Part 11, GAMP 5 and a strong knowledge of Data Integrity requirements.Demonstrable experience of CAPA management.Knowledge of infrastructure qualification.Good technical IT knowledge.Excellent leadership and team management skills.Strong communication and interpersonal abilities to work effectively with cross-functional teams.Attention to detail and a strong commitment to quality assurance and compliance.

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