.**Purpose**The Quality Manager, Lifecycle Safety, is responsible for quality, compliance and deviation management across global Lifecycle Safety functions including ICSR case processing, Regulatory reporting, Medical Information, endpoint adjudication and aggregate reporting. The Quality Manager will partner with Lifecycle Safety functional specialists and/or management to assess quality trends, processes and procedures for continued improvement opportunities including CAPA management.The Quality Manager will support Lifecycle Safety Functions with preparation, including training for audits and inspection, hosting of those audits and inspections and will support CAPA owners to resolution. The Quality Manager may also support our Lifecycle Safety clients with Quality Management activities on their accounts.**Responsibilites**- Adopt and implement the Global Quality Management Plan within the scope of the assignment; this will include:- planning and executing the Quality Management activities; - risk identification and assessment through data review and quality control processes either remote or on site; - providing support in risk mitigation, in planning corrective/preventive actions and guidance for improvement; - Review Non compliance & Deviation reports for accuracy, RCA and CAPA plans- Cooperate closely with the relevant Heads of business and other stakeholders, support maintaining focus on quality in project delivery. Contribute to the development and implementation of a Regional/Delivery Unit/Sponsor specific Quality Management Plan and Risk Management Program, monitor the implementation and delivery.- Provide advice and support to functional operational teams within the Lifecycle Safety Department including ICSR case processing, Regulatory reporting, Medical Information, endpoint adjudication and aggregate reporting- Work in close cooperation with operational teams to manage non-compliance, quality issues; assist in planning corrective/preventive actions, as applicable according to SOPs.- Inform Heads of Quality Management, Heads of the assigned business line and Quality Assurance of quality issues according to SOPs.- Work closely with Quality Assurance and assigned business staff in case of suspected misconduct; as required by the applicable SOPs.- Provide assistance during audits and regulatory inspections to the operational teams to the extent agreed with the Head of QM and as required by the applicable SOPs.- Act as the primary contact for Quality Assurance on clinical quality matters - on the level of the assignment -, attend meetings/teleconferences.- Prepare periodic reports to Heads of Quality Management and to stakeholders on quality related matters, risk assessments and specific quality improvement initiatives