Job Description

What the Senior Auditor, Quality Assurance does

To have in-depth experience and working knowledge in appropriate GxP compliance and other applicable regulations in order to conduct various types of audits to assess Worldwide Clinical Trials (WCT) Worldwide Clinical Trials (WCT) processes and procedures, applicable regulations and Sponsor SOPs, when necessary. Provides guidance on regulatory compliance to internal clients. Provides direction and coordination of project activities related to assigned areas in liaison with QA management. Mentors other QA auditors. The Senior (Sr.) Quality Assurance Auditor works under the general supervision and guidance of the Manager, QA, Sr. Manager, QA, Director, QA or Sr. Director, QA.

What you will do

• Works with the QA Management to plan, conduct and complete written reports for each audit assigned.
• Monitors the projects and audit status in assigned areas and provides QA Management with current status upon request.
• Assists with the management of the Vendor Audit program.
• Facilitates sponsor audits/regulatory inspections, as assigned.
• Assists QA Management with review of audit reports to identify improvements that enhance the quality and clarity of the reports.
• Fosters a good working relationship with internal clients and QA team.
• Identifies areas for process improvement and provides this information to management.
• Assists with corrective and preventive action plans (CAPAs) to assure follow-up and implementation of corrections for internal and external audits.
• Provides advice and guidance on regulatory requirements and SOPs.
• Assists with training and mentoring of less experienced auditors.
• Assists with creating and presenting GCP/GLP and other related training sessions.
• Assists QA Management with review of WCT policies and procedures.
• Oversees the maintenance of records for each audit.

What you will bring to the role

• Sound knowledge of applicable GxP regulations and requirements as well as WCT policies and procedures.
• Ability to coordinate multiple projects and have the flexibility needed to adjust to changing priorities and unforeseen events.
• Ability to use logical inferences to understand the “big picture” and long term implications of these issues.
• Ability to interact professionally and to work independently or in teams.
• Excellent oral and written skills.
• Ability to prioritize work and define steps needed to achieve assigned project goals.
• Ability so speak, read and write English fluently.
• Experience with Microsoft Word applications and to learn internal computer systems as necessary

Your experience

• Bachelor’s Degree preferably in life science and a minimum five (5) years’ experience in regulatory affairs, auditing, clinical research, monitoring, laboratory, or other relevant area, three (3) of those years must be in quality assurance auditing. Additional experience in a relevant area (clinical setting, laboratory) that is deemed equivalent to education may be applied in lieu of the education requirement.

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