Senior Director - Quality Assurance

It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. Why Worldwide What the Senior Director QA Audits and Inspection Programs does at Worldwide Director of QA Audit and Inspection Program is responsible for the Strategic Vision, oversight, planning, execution, reporting and quality management of QA Audit & Inspection Program reporting to the EVP Global Head of Quality. Act as the QA Global head for the QA Audits & Inspections reporting directly to the EVP Global Head of Quality Plans, adjusts, manages and optimizes all resources (budgets, staff and technologies) for the advancement of the QA’s goals and objectives for the Audit & Inspection Program Oversees, monitors and reports on all internal and external QA audits to ensure timely completion of applicable CAPAs to prevent reoccurrence and to drive process improvements Defines, monitors, tracks and reports Key Quality Indications (KQI) and Quality Tolerance Limits (QTL) for the Audit & Inspection Program Oversees the management, planning, hosting, reporting, documentation and follow up of all GCP Regulatory Inspections and Sponsor audits Serves as the Subject Matter Expert on QA Quality Management Processes for Audits and Inspections Demonstrates excellent project management and decision-making skills Communicates professionally, concisely, clearly and consistently to external and internal customers both verbally and in writing Demonstrates ability to work collaboratively with cross functional stakeholders to drive process improvements based on Quality Indicators Demonstrates the ability to implemented risk management strategies Previous experience with leading/participating in FDA BIMO inspections, MHRA GCP inspections, Health Canada GCP inspections, EMA GCP inspections, and other international Regulatory inspections is required Excellent understanding of the principles for a GCP Quality Management System Possesses broad experience related to understanding the principles and application of quality and regulatory compliance related to GxP activities, specifically GCP Previous experience in preparing an organization for GCP Regulatory Inspection and being the primary lead of GCP Inspections for MHRA, Health Canada, EMA, or FDA in the last 2 years. Demonstrated experience for implementing GCP inspection readiness activities and tools in past 2 years. Excellent experience in conducting QA Audits, specifically GCP for each type (Clinical Investigator Audits, Vendor Audits, Internal Process Audits) in last 5 years. Excellent understanding or risk-based approaches to auditing Demonstrated experience for leading Sponsor Audits independently Previous experience in trending and analysis methodologies Understanding of 21 CFR Part 11 regulations and other international guidelines specifically addressing Computer Systems Electronic Record/Electronic Signature (ERES) Ability to speak, read and write English fluently S. in a scientific or allied health filed and 7+ years of relevant GCP, GcLP, GLP, GVP and GPP experience IT literate, experienced with Microsoft based applications, including proficiency in Excel, Word, Trackwise, SharePoint, and PowerPoint. Domestic and international travel required (approximately 25%) For more information on Worldwide, visit or connect with us on .