Worldwide Clinical Trials
Senior Auditor, Audits and Inspections Program - US/Canada - Remote
Worldwide Clinical Trials, Raleigh, North Carolina, United States
Senior Auditor, Audits and Inspections Program - US/Canada - Remote
Join
Worldwide Clinical Trials
as a Senior Auditor in our Audits and Inspections Program (Remote, US/Canada).
About Us We’re a global, midsize CRO that pushes boundaries, innovates, and invents to cure persistent diseases. Our team of over 3,500 experts is committed to quality, excellence, diversity, and inclusion.
Why Worldwide We believe everyone plays an important role in improving lives. We provide a diverse and inclusive environment that encourages collaboration, creativity, and success.
Quality Assurance Department The QA department sets a high bar for quality, exceeding standards required by sponsors, study participants, and regulatory authorities. We empower staff to deliver high-quality products.
What You Will Do
Champion and adhere to Worldwide’s Quality Management System (QMS).
Serve as a positive ambassador of the QA organization with internal and external customers.
Develop and execute personal and QA goals and objectives.
Host external audits and regulatory inspections.
Ensure quality deliverables are on time and comply with regulations and Worldwide processes.
Oversee, monitor, and report on QA audits to ensure timely completion of applicable CAPAs to prevent reoccurrence and drive process improvements.
Maintain and archive records for each audit.
Participate in driving continuous process improvements.
Participate in the development and review of AIP Quality Management Documents.
Assist in developing training material and deliver training related to audits and inspections.
Act as Subject Matter Expert on QA Quality Management processes for audits.
Communicate relevant regulatory intelligence impacting the QMS to the QA team.
What You Will Bring To The Role
Broad expertise in principles and application of quality and regulatory compliance related to GxP activities.
Excellent knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments, and AIFA CRO Decree.
Experience in conducting QA Audits, specifically GCP for various audit types (Clinical Investigator Audits, Vendor Audits, Internal Process Audits, For‑cause Audits, Document Audits, etc.).
Experience in trending and analysis methodologies.
Your Experience
M.S. in a scientific or allied health field and 5+ years of relevant GCP, GcLP, GLP, GVP, and / or GPP experience.
Strong understanding of the Drug Development Process.
Minimum 3 years of Quality Assurance auditing experience.
IT literate, proficient in Microsoft applications (Excel, Word, Trackwise, SharePoint, PowerPoint).
Occasional domestic travel required.
We love knowing that our work improves lives. Explore other roles at our careers page or visit
www.Worldwide.com
or connect on LinkedIn.
Worldwide is an equal opportunity employer committed to diversity and inclusion. 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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Worldwide Clinical Trials
as a Senior Auditor in our Audits and Inspections Program (Remote, US/Canada).
About Us We’re a global, midsize CRO that pushes boundaries, innovates, and invents to cure persistent diseases. Our team of over 3,500 experts is committed to quality, excellence, diversity, and inclusion.
Why Worldwide We believe everyone plays an important role in improving lives. We provide a diverse and inclusive environment that encourages collaboration, creativity, and success.
Quality Assurance Department The QA department sets a high bar for quality, exceeding standards required by sponsors, study participants, and regulatory authorities. We empower staff to deliver high-quality products.
What You Will Do
Champion and adhere to Worldwide’s Quality Management System (QMS).
Serve as a positive ambassador of the QA organization with internal and external customers.
Develop and execute personal and QA goals and objectives.
Host external audits and regulatory inspections.
Ensure quality deliverables are on time and comply with regulations and Worldwide processes.
Oversee, monitor, and report on QA audits to ensure timely completion of applicable CAPAs to prevent reoccurrence and drive process improvements.
Maintain and archive records for each audit.
Participate in driving continuous process improvements.
Participate in the development and review of AIP Quality Management Documents.
Assist in developing training material and deliver training related to audits and inspections.
Act as Subject Matter Expert on QA Quality Management processes for audits.
Communicate relevant regulatory intelligence impacting the QMS to the QA team.
What You Will Bring To The Role
Broad expertise in principles and application of quality and regulatory compliance related to GxP activities.
Excellent knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments, and AIFA CRO Decree.
Experience in conducting QA Audits, specifically GCP for various audit types (Clinical Investigator Audits, Vendor Audits, Internal Process Audits, For‑cause Audits, Document Audits, etc.).
Experience in trending and analysis methodologies.
Your Experience
M.S. in a scientific or allied health field and 5+ years of relevant GCP, GcLP, GLP, GVP, and / or GPP experience.
Strong understanding of the Drug Development Process.
Minimum 3 years of Quality Assurance auditing experience.
IT literate, proficient in Microsoft applications (Excel, Word, Trackwise, SharePoint, PowerPoint).
Occasional domestic travel required.
We love knowing that our work improves lives. Explore other roles at our careers page or visit
www.Worldwide.com
or connect on LinkedIn.
Worldwide is an equal opportunity employer committed to diversity and inclusion. 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.
#J-18808-Ljbffr