Senior Auditor, Audits and Inspections Program - US/Canada - Remote

Worldwide Clinical Trials - USA; North Carolina; Remote; USD 70,000 - 100,000; Full time

Job summary

A leading global CRO is seeking a Quality Assurance professional to uphold high standards in quality management. The role involves overseeing audits, ensuring regulatory compliance, and contributing to continuous process improvements. Ideal candidates possess a Master's degree and significant experience in GxP activities, specifically GCP.

Qualifications

• 5+ years of experience in GCP, GLP, GVP, and/or GPP.
• Minimum 3 years of QA auditing experience.
• Excellent working knowledge of ICH Guidelines and FDA regulations.

Responsibilities

• Hosts external audits and regulatory inspections.
• Develops and executes QA goals and objectives.
• Ensures timely completion of audits and CAPAs.

Skills

Regulatory Compliance

Audit Conducting

Trend Analysis

Education

M.S. in a scientific or allied health field

Tools

Microsoft Excel

Trackwise

SharePoint

Job description

Who we are

We’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 Worldwide

We 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 Worldwide

The 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 do

• Champions and adheres to Worldwide’s Quality Management System (QMS).
  

• Serves as a positive ambassador of the QA organization with internal and external customers.
  

• Develops and executes to personal and QA goals and objectives.
  

• Hosts external audits and regulatory inspections.
  

• Ensures quality deliverables, on time, and in compliance with regulations and Worldwide processes.
  

• Oversees, monitors and reports on QA audits to ensure timely completion of applicable CAPAs to prevent reoccurrence and to drive process improvements.
  

• Oversees the maintenance and archiving of records for each audit.
  

• Participates in the driving continuous process improvements.
  

• Participates in the development and review of AIP Quality Management Documents, as assigned.
  

• Assists in developing training material and/or delivers training related to audits and inspections.
  

• Serves as a Subject Matter Expert on QA Quality Management processes for audits.
  

• Communicates relevant regulatory intelligence that has impact on the QMS to the QA team.
  

What you will bring to the role

• Possesses broad expertise related to understanding the principles and application of quality and regulatory compliance related to GxP activities.
  

• Excellent working knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments, and AIFA CRO Decree.
  

• Possesses broad experience related to understanding the principles and application of quality and regulatory compliance related to GxP activities, specifically GCP.
  

• Excellent 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 methodologies.
  

Your experience

• M.S. in a scientific or allied health filed and 5+ years of relevant GCP, GcLP , GLP, GVP, and / or GPP experience.
  

• Excellent understanding of the Drug Development Process.
  

• Minimum 3 years of Quality Assurance auditing experience.
  

• IT literate, experienced with Microsoft based applications, including proficiency in Excel, Word, Trackwise , SharePoint, and PowerPoint.
  
• Occasional domestic traveling required.
  

We love knowing that someone is going to have a better life because of the work we do.

To view our other roles, check out our careers page at Discover a world of difference at Worldwide !For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn .

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’reon a mission to hire thevery bestand 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.