Director Of Quality Excellence

Director of Quality Excellence - Legal; Risk & ComplianceJob DescriptionPosted Friday, October 31, **** at 7:00 AMAt Signant Health, we help bring life-changing clinical trials to patients around the world.As a global leader in digital solutions for clinical research, we partner with top pharmaceutical companies, biotechs, and CROs to simplify trial execution, improve data quality, and accelerate the development of new therapies.Our people are at the heart of our mission — we foster innovation, collaboration, and growth in everything we do.We are looking for a Director of Quality Excellence to join our teamThe Director of Quality Excellence is a key member of the Quality Management Leadership Team with the following primary responsibilities.Quality Operational Excellence – identifying opportunities and supporting and providing project management of Quality Management initiativesManagement of data input into matrix management tool, monitor progress, and assist in the contributors' accountability processQuality innovation and groundbreaking projectsRepresent Quality on various internal and external meetingsSite Quality goal and metrics governanceStrategic Quality planningSupplier Quality Management and Internal Audit Program oversightKEY ACCOUNTABILITIESDrive Quality Operations Strategy ensuring strategic initiatives are structured and managed to assure quality deliverables and on time acceptanceManage the quality system to ensure alignment with regulatory standards and guidance.Drive a continuous improvement philosophy to ensure effective delivery of a quality system that consistently meets regulatory and client requirementsEnsure new and revised regulatory standards, guidance and frameworks are assessed and changes are implementedEstablish and manage a centralized Project Management Office for Quality Management for management of continuous improvement projects in support of quality strategic goalsProject Manage quality operations process improvement initiatives in partnership with the process owner and relevant stakeholders through the central project management officeHold all contributors tightly accountable in accordance with plans, project charters, milestones, and determine project targets with quantifying and tracking metrics for quality operations continuous improvementEstablish training material to support the quality organization for initial and ongoing process improvement initiativesWork with relevant cross-functional teams to investigate operational/process inefficiencies for the identified initiatives and working with the business to design improvements and implement efficient/effective systemsLead quality goals monitoring, tracking, and interventionKNOWLEDGE, SKILLS & ATTRIBUTESDemonstrated ability (at least 10 years of leadership experience, 15 years total, includingstrategic project management and leadership coordination of activities).Proven experience in a GxP regulated environment (e.g. FDA, EMA, ICH, PIC/S).Knowledge of and experience with developing culture & demeanor and project activities to continually improve compliance and operational efficiencyProven track record to inspire changes and support organizational change processesProven strategic and business oriented thinkingDemonstrated ability to drive innovation, continuous improvement and out-of-the-box thinkingStrong interpersonal skills and ability to communicate ideas and data both verbally and in writing.Strong influencing and partner leadership skillsAnalytical and critical thinking skillsProblem solving and continuous improvement skills (facilitation and applications of tools)Knowledge of Computer Systems Validation (CSV)At Signant Health, accepting difference isn't enough—we celebrate it, we support it, and we nurture it for the benefit of our team members, our clients and our community.Signant Health is proud to be an equal opportunity workplace and is an affirmative action employer.We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status.#J-*****-Ljbffr