Who We AreWe're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's 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 Quality Assurance Department Does At WorldwideThe Quality Assurance department sets the bar high when it comes to quality.
We are committed to exceeding the quality standards required by our sponsors, study participants, and regulatory authorities.
Our QA culture is based on an environment where staff are trained, energized, and empowered to deliver high-quality products to our employees and customers.What You Will DoChampions and adheres to Worldwide's Quality Management System (QMS)Serves as a positive ambassador of the QA organization with internal and external customersDevelops and executes to personal and QA goals and objectivesPerforms QA audits for Vendors, Internal Process, Clinical Investigator, Document (Clinical Study reports, Trial Master File, Database) and other audits, as assignedEnsures quality deliverables, on time, and in compliance with regulations and Worldwide processesOversees, monitors and reports on QA audits to ensure timely completion of applicable CAPAs to prevent reoccurrence and to drive process improvementsOversees the maintenance and archiving of records for each auditParticipates in the driving continuous process improvementParticipates in the development and review of AIP Quality Management Documents, as assignedProvides support to Sponsors Audits and Inspections in relation to Worldwide provided servicesAssists in developing training material and/or delivers training related to audits and inspectionsServes as a Subject Matter Expert on QA Quality Management processes for auditsCommunicates relevant regulatory intelligence that has impact on the QMS to the QA teamWhat You Will Bring To The RolePossesses broad expertise related to understanding the principles and application of quality and regulatory compliance related to GxP activitiesExcellent working knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments, and AIFA CRO DecreePossesses broad experience related to understanding the principles and application of quality and regulatory compliance related to GxP activities, specifically GCPExcellent experience in conducting QA Audits, specifically GCP for each type (i.e.
Clinical Investigator Audits, Vendor Audits, Internal Process Audits, For-cause Audits, Document Audits, etc.
)Previous experience in trending and analysis methodologiesYour ExperienceM.S.
in a scientific or allied health field and 5+ years of relevant GCP, GcLP, GLP, GVP, and/or GPP experienceExcellent understanding of the Drug Development ProcessMinimum 3 years of Quality Assurance auditing experienceIT literate, experienced with Microsoft based applications, including proficiency in Excel, Word, Trackwise, SharePoint, and PowerPoint.Domestic and international travel requiredWe love knowing that someone is going to have a better life because of the work we do.Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity.
We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful.
We're on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity.
We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.
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