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REPORTING TO: | CS CR Associate Director-Quality Assurance |\n\nRESPONSIBLE FOR (PEOPLE):  N/A  \nOVERALL ROLE OBJECTIVE:  \nThe role of the Quality Technical Lead is to act as the nominated Quality SME, providing support on specific local or global projects that require Quality input and expertise so that they are appropriately supported. In addition, the role will facilitate the implementation of new processes (or significant changes) within the Quality department and risk assessment activities specific to their area.  \nJOB SPECIFIC RESPONSIBILITIES:  \nPrinciple Duties  \nThe post holder will:  \n1 Act as the Quality SME on local or global projects to which you are assigned. In doing so:  \n• Work closely with the sponsor, key stakeholders and project team  \n• Provide Quality input into the user requirements gathering and support the generation and approval of any associated change control , risk assessment and validation documentation  \n• Capture key decisions and provide regular updates to global Quality Management, highlighting any areas of concern and gain consensus on any discussion points requiring resolution  \n• Identify impacts and compliance risks and highlight to the project team  \n• Ensure deliverables to which you are assigned are completed in a timely manner  \n• Communicate updates to the wider Quality teams as required  \n2 Facilitate the implementation of new processes or significant changes within the Quality department. In doing so:  \n• Work closely with Quality management (locally or globally) to define the scope of the initiative or change  \n• Lead the implementation exercise, track tasks and monitor progress, providing clear visibility of key milestones and deliverables  \n• Facilitate the user requirements gathering and support the generation of process / data maps and the compilation and approval of any associated change control , risk assessment and validation documentation  \n• Work closely with department SMEs in order to generate / update SOPs  \n• Work closely with department OJT in order to develop educational material relevant to the changes being introduced  \n• Provide regular updates to local or global Quality Management, highlighting any areas of concern, gain consensus on any discussion points requiring resolution and report on project status  \n• Identify impacts and compliance risks and highlight to the project team  \n• Highlight potential inter-dependencies and identify business readiness activities  \n• Facilitate effectiveness checks  \n3 Facilitate process and data integrity Risk Assessments within the Quality department and identify continuous improvements to reduce risk, enhance efficiency and compliance within the department.  \n4 Support other departments via the provision of expert Quality advice and guidance to ensure GxP compliance. In doing so, keep abreast with current regulations and an awareness of industry expectations and best practices.  \nExpectations regarding Communication  \n5 Provide Quality management (locally and globally) with regular, clear and concise updates on the status of activities in which you are involved.  \n6 Escalate matters of concern to Quality management or appropriate business representatives in order to ensure satisfactory resolution.  \n7 Communicate clearly with business representatives (locally and globally) on any initiatives to which you are assigned.  \n8 Act as an SME during regulatory inspections and customer calls / audits / visits when discussing matters relating to initiatives in which you are involved.  \n9 Ensure all internal / external contact, oral and written, is carried out professionally in order to develop and maintain good working relationships.  \n10 Maintain a professional approach at all times whilst representing Clinical Services.  \nQuality Specific Duties  \n11 Ensure high atten","cbCaid8jEmqupWRh","https://ap.wps.com/l/cbCaid8jEmqupWRh","pdf",227056,"English","# Overall role objective\n## Principle duties\n## Quality-specific duties\n## General role responsibilities\n## Expectations regarding communication","[{\"question\":\"What is the overall objective of the Quality Technical Lead role?\",\"answer\":\"To act as the nominated Quality SME supporting local/global projects with required quality input, and to facilitate implementation of new or changed quality processes along with area-specific risk assessment activities.\"},{\"question\":\"Which responsibilities relate to project quality support?\",\"answer\":\"The role provides quality input into user requirements, supports change control, risk assessment and validation documentation, captures key decisions with updates, identifies compliance risks, and ensures assigned deliverables are completed on time.\"},{\"question\":\"How does the role contribute to compliance and continuous improvement?\",\"answer\":\"It performs process and data integrity risk assessments, supports CAPA actions and addendums, escalates when quality standards fall short of GxP, and supports inspections, audits, and effectiveness checks.\"}]","CS CR Quality Technical Lead - Job Description - 30 March 2026 | PDF"]