Global Operations Quality Manager

Global Operations Quality ManagerSyneos 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. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. 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. Discover what your 25,000 future colleagues already know: 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. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job ResponsibilitiesUnder the leadership of the Director of Development Operations Quality (DOQ) or designee, this position is responsible for DOQ collaborations with Global Monitoring and Clinical Study Support and Regional Clinical Operations. This position leads collaborations at country and regional level, as assigned. This position leads consultation on continuous improvement of established processes and procedures. This position provides global strategic and tactical leadership within our study teams to achieve overall quality goals while always maintaining inspection readiness. This position may sit across the entireglobal portfolio or a particular asset(s). These activities will be in collaboration with Quality Assurance (QA) and the Quality Lead/Specialist, as needed. With QA leading, this position supports study teams during regulatory inspections.General Responsibilities Develop and maintain guidance and process to facilitate DOQ support of Study TeamsDevelop, contribute, and support facilitation, presentation, and communication of GCP Lessons Learned, GCP Cases, or other trending analysisProvide training or awareness for new or established processes or guidance provided by DOQCollaborate in developing and presenting DOQ content for distribution within the organizationAuthor relevant content for the DOQ SharePoint siteAct as lead on specified DOQ workstreams or assigned DOQ initiativesIn collaboration with the Operations Quality Lead/Specialist, provide consultation and support for ad hoc requests that are sent to DOQConsult, develop, or identify opportunities for continuous improvement projectsDevelop, review, and analyze KQI or metrics that may identify emergent issues or trends or demonstrate strong adherence to quality within Development OperationsStay current with knowledge of clinical trial requirements, ICH GCP guidelines, and global regulatory requirements for the management of clinical trialsFacilitate and support cross-functional stakeholder engagement to ensure adequate representation for consultation towards consensusDevelop matrix relationships to involve process experts and conduct improvement activitiesCollaborate with DOQ Leadership to ensure integration, alignment, and consistent messaging across the organizationPromote a culture of quality, continuous improvement, and operational excellence that engages colleagues in positive dialogue consulting and supporting in all we do Skills/ExperienceWorking knowledge of Quality Management methods, systems, and relevant proceduresExperience in providing quality management within Study Teams in the conduct and management of large and complex multinational clinical trialsExperience in managing complex and sensitive operational challengesExperience in risk and issue management and in assessment of non-compliance against relevant study documents, procedures, ICH GCP, and regulatory requirementsAdept at identifying and investigating issues, identifying root cause, and able to facilitate cross-functional solutions with stakeholdersExperience in developing or contributing to processes and/or SOPs and/or WIsAbility to lead and execute continuous improvementExperience in inspection preparation, participation, and follow-