Description Single Sponsor Manager, Quality Assurance - 2-3 days in London CitySyneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Why Syneos Health• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.• We are committed to building an inclusive culture - where you can authentically be yourself. We are continuously building the company we all want to work for and our customers want to work with. On a regular basis support the Clinical Compliance Quality Management team with local trends, root-cause-analysis and local action plan. (as required)Processes & Regulations: -Local expert for ICH-GCP , local regulations and any quality-related process.-Support CCQM to manage the local SOP/SME network to ensure a proper implementation of global/regional/local procedures and the regular update of local SOPs. -Support quality improvement activities upon request of the CCQM Lead/CRD.Training: - Support local training (as needed)Quality Control (QC) Activities: -Support CCQM in the coordination and proper execution of all QC activities at country/cluster i.e. In-house Quality Control Plan (IHQCP) , Quality Control Visits (QCVs), etc. -Perform QC activities and site visits (upon request)-Support CCQM with local trends, root-cause-analysis and local action plan (as required)Quality / Compliance / Privacy Issue Escalation:- Communicate/escalate quality/compliance issues (incl. any potential trends) to local country operations management and CCQM Lead.- If indicated, escalate significant quality/compliance issues and supports investigations (fact finding, root-cause-analysis) as well as the reporting of ‘Serious Breaches’, if applicable.Bachelor's Degree.-Relevant experience in clinical quality management, plus direct field monitoring experience or operations management. Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required.- Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.- Experience in quality management / compliance (e.g. audit/inspection support incl. CAPA management, SOP management, compliance issue management, training, etc. ) Working knowledge of digital and AI-enabled ways of working, including experience with tools such as Power BI, Power Apps, automation technologies, data analytics, and related digital solutions.Further, nothing contained herein should be construed to create an employment contract. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Quality Coordinator: Quality Assurance & Compliance in London employer: Syneos Health
At Syneos Health, we pride ourselves on being an exceptional employer that prioritises the growth and development of our employees. With a strong commitment to career progression, comprehensive training, and a supportive work culture, we foster an inclusive environment where diverse perspectives are valued. Our remote monitoring role offers the unique advantage of flexibility while contributing to meaningful clinical research that impacts lives across the UK.
