Senior Auditor, Audits and Inspections Program

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!

*SUMMARY: *The Senior Auditor, Audits and Inspections Program is responsible for planning, executing, reporting and following up on GxP QA Audits & supporting Regulatory Inspections as assigned. *RESPONSIBILITIES:* • 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 • Adheres to Worldwide travel policy and QA budgets • Performs QA audits for Vendors, Internal Process, Clinical Investigator, Document (Clinical Study reports, Trial Master File, Database) and other audits, as assigned • 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 with tracking and reporting of Key Quality Indications (KQI) and Quality Tolerance Limits (QTL) for the Audit & Inspection Program • Provides support to Sponsors Audits and Inspections in relation to Worldwide provided services • Assists with lessons learned opportunities following audits to allow for transfer of knowledge and training • Ensures data and record management in accordance with the QMS • 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 • Participates in employee performance appraisals as per Worldwide processes • Performs other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive *OTHER SKILLS AND ABILITIES:* • Ability to work with minimal supervision and guidance • Demonstrates excellent organizational leadership competencies, inclusive of scheduling and leading team meetings that are effective, efficient and documented • Demonstrates excellent decision-making and project management skills • Demonstrates excellent ability to effectively communicate and influence the outcomes of decision-making process • Communicates professionally, concisely, clearly and consistently to external and internal customers both verbally and in writing • Acts with authority to drive performance and accountability • Ability to lead a team of individuals with a clear vision and defined purpose • Demonstrates excellent skillset for influencing, being resourceful, managing conflict and negotiating • Demonstrates an excellent aptitude for facilitating group or project initiatives and building team unity • Works with a sense of urgency; ability to recognize time sensitivity and leads assertively • Demonstrates an excellent understanding of clinical research principles and processes for clinical trials • Demonstrates ability to work collaboratively with cross functional stakeholders to drive process improvements based on Quality Indicators • Demonstrates the ability to implement risk management strategies *REQUIREMENTS:* • Possesses broad expertise related to understanding the principles and application of quality and regulatory compliance related to GxP activities • Excellent understanding of the principles for a GCP Quality Management System • Ex