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 WorldwideWhat the Senior Director QA Audits and Inspection Programs does at WorldwideDirector 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 QualityPlans, adjusts, manages and optimizes all resources (budgets, staff and technologies) for the advancement of the QA’s goals and objectives for the Audit & Inspection ProgramOversees, monitors and reports on all internal and external QA audits to ensure timely completion of applicable CAPAs to prevent reoccurrence and to drive process improvementsDefines, monitors, tracks and reports Key Quality Indications (KQI) and Quality Tolerance Limits (QTL) for the Audit & Inspection ProgramOversees the management, planning, hosting, reporting, documentation and follow up of all GCP Regulatory Inspections and Sponsor auditsServes as the Subject Matter Expert on QA Quality Management Processes for Audits and Inspections
Demonstrates excellent project management and decision-making skillsCommunicates professionally, concisely, clearly and consistently to external and internal customers both verbally and in writingDemonstrates ability to work collaboratively with cross functional stakeholders to drive process improvements based on Quality IndicatorsDemonstrates the ability to implemented risk management strategiesPrevious experience with leading/participating in FDA BIMO inspections, MHRA GCP inspections, Health Canada GCP inspections, EMA GCP inspections, and other internationalRegulatory inspections is required
Excellent understanding of the principles for a GCP Quality Management SystemPossesses broad experience related to understanding the principles and application of quality and regulatory compliance related to GxP activities, specifically GCPPrevious 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 auditingDemonstrated experience for leading Sponsor Audits independentlyPrevious experience in trending and analysis methodologiesUnderstanding 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 fluentlyS. in a scientific or allied health filed and 7+ years of relevant GCP, GcLP, GLP, GVP and GPP experienceIT 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 ….