Susan Cross Email and Phone Number

As the Response Management Team (RMT) Lead I am responsible for reviewing and ensuring the adequacy of the CAPAs for Critical and Major Quality Issues, irrespective of source and Minor QIs generated from Regulatory Inspections and Client Site/System Audits. The RMT will work closely with the Site Managers / Functional Group Lead or Delegate to manage the CAPAs. Mentor new/junior members of the Response Management Team to ensure goals of the QA RMT are met.Maintain and managed current eQMS until transition to new systemSupport implementation of new eQMS for Quality Issues and CAPA Management module. Responsible for creating training material when required and delivering said training.

Management of training on the eQMS and to provide high quality training to both the business and the Quality Department. Main responsibilities of the role will include:• Develop and manage mandatory training courses (in conjunction with SME where applicable) internally and delivered online using the new eQMS system.• Develop assessments for mandatory training .• Develop procedural assessments for selected procedures .• Identify and assess future and current training needs through feedback from stake holders within the business. Once identified develop training modules/programmes tailored to the needs of the business and/or Quality Department that meet the training requirements of the end use.    • Act as the SME for training on the eQMS and develop and maintain user manual.• Work with HR collaboratively on the management of training records on the eQMS.• Act as the eQMS owner to include training on use of the system and provide follow up training on updates to the system (e.g. new software releases)• Manage regulatory intelligence and interpretation including impact on business and processes.• Perform audits at the request of the business.• Where required peer review audit reports and Quality Issues (QI)• Where required act as root cause analysis (RCA) facilitator.• Where required conduct reviews of Synexus formal procedures.

Work within the Quality Department with minimum supervision on the following:Perform QA responsibilities including:internal routine audits and training to ensure consistency and compliance of Operations across all centresPerform complex audits at short notice.investigation of suspected non compliances and follow up of CAPA from audits and other Quality measures.Develop Quality Systems, processes and procedural improvements that deliver increased efficiency and other benefits.Active part of the Quality Team and work with other team members to manager quality activities.Provide effective training, coaching and mentoring to junior members of the Quality Team as required.Perform peer reviews of audit reports etc as required.

As a Clinical Quality Auditor with Synexus my role includes the following:Perform Quality Assurance responsibilities including Internal Audits and Training to ensure consistency and compliance of operations across all Centres both UK and Internationally.To work with Synexus personnel to develop, improve and implement global working practices and systems, in compliance with GCP and appropriate regulations.To enhance the reputation for provision of quality of data and to provide expert advice and service to customers.Work within the Quality team promoting best practice.To produce concise and informative audit reports and follow up with relevant personnel to ensure CAPA implemented.In the absence of the Director of Quality, be the key customer contact for quality related communication e.g. vendor audits, site audits and regulatory inspections.Active member of the CAPA team providing expertise and feedback on items for discussion including coordination and tracking of CAPA process to completion.Maintain awareness of regulatory changes and act as a point of contact for Synexus staff, providing information and expert guidance on regulations and procedures

Supports the Country Head of Clinical Operations (HCO) to drive quality management, implement process improvements, provide training, ensure compliance with Global and local SOPs and processes, ensure regulatory compliance, inspection readiness and provide oversight required to ensure operational effectiveness and high quality performance of Clinical Operations (COs)

The role of CCO-QC supports the Country Head of Clinical Operations to promote quality management, process improvements, training, regulatory compliance, inspection readiness and oversight required to ensure operational effectiveness and high quality performance of the Country Clinical Operations.In order to ensure that the MREC submissions are made a full understanding of the MREC process within the UK is required, ICH GCP in order to ensure patient information leaflets and supporting documentation meet the necessary requirements and in order to ensure adherence with the regulatory requirements a good understanding of the Statutory Instrument is also required along with awareness of the ABPI code of conduct. I am up to date on the changes within NRES and am on the working party for the IRAS system. I am the main point of contact for any queries / issues in relation to ethics and work closely with the Quality Standards Manager and the REC co-ordinators ensuring an excellent relationship is maintained.