Job Title

Who we areWere a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the worlds most persistent diseases is not paved by those who play it safe. 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.Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.Why WorldwideWe believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!What the Senior Director QA Audits and Inspection Programs does at Worldwide The Sr. 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.What you will do 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 QAs 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 InspectionsWhat you will bring to the role Demonstrates excellent organizational leadership competences, inclusive of scheduling and leading team meetings that are effective, efficient and documentedDemonstrates excellent project management and decision-making skillsCommunicates professionally, concisely, clearly and consistently to external and internal customers both verbally and in writingDemonstrates an excellent understanding of clinical research principles and processes for clinical trialsDemonstrates 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 requiredYour experience Excellent understanding of the principles for a GCP Quality Management SystemExcellent working knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments, AIFA CRO DecreePossesses broad experience related to understanding the principles and application of quality and regulatory compliance related to GxP activities, specifically GCPGcLP, GLP, GVP, GPP, Device and GMP knowledge requiredPrevious 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)Excellent understanding of the Drug Development ProcessProven experience in developing, managing and complying with annual budgetsAbility to speak, read and write English fluentlyM.S. in a scientific or allied health filed and 7+ years of relevant GCP, GcLP, GLP, GVP and GPP experienceOrFour-year college curriculum with concentration in nursing, biological, physical, health, pharmacy or other related science and 10+ years of relevant GCP, GLP, GVP experienceAnd 8-10 years of strong managerial experienceIT literate, experienced with Microsoft based applications, including proficiency in Excel, Word, Trackwise, SharePoint, and PowerPoint.Domestic and international travel required (approximately 25%)We love knowing that someone is going to have a better life because of the work we do.For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.