Oversees the conduct of audits and conducts audits in accordance with QA SOPs and WIs;
Responsible for generating own and reviewing others’ audit reports;
Prepares for and hosts or supports customer audits in accordance with QA SOPs and WIs. Coordinates responses to customer audits of investigator sites, and resolves issues with customers, where applicable;
Plans and provides strategies for assessing readiness of Syneos Health offices for potential Regulatory Inspections and conducts such assessments (e.g. develops a program for and conducts ‘mock inspections’). Develops and delivers inspection readiness training to staff;
Prepares for and hosts or supports Regulatory Authority Inspections in accordance with QA SOPs and WIs. Coordinates the preparation and support activities for inspections by Regulatory Authorities, including compilation of any pre-inspection required information;
Communicates findings from customer audits and Regulatory Authority Inspections of Syneos Health promptly to appropriate Syneos Health personnel and provides support on root cause analysis, corrective and preventive actions;
Provides consultancy on quality related matters as needed;
Proposes strategies for improvements to quality and compliance of Operations and services;
May participate in and direct activities related to department staff operations such as interviewing and selection, professional development, performance management, employee counseling and separations. Works with and advises staff on administrative policies and procedures, technical problems, priorities and methods;
May have line management responsibilities for staff members. If so, builds and maintains an organization that meets the needs of Syneos Health and its customers and ensures that his / her direct reports deliver against the budget, timeline, and quality requirements.
Functional and Technical Expertise
Knowledge of Medical and technical terminology related to the audit types to be conducted.
Anticipates and resolves key technical, operational, or business problems related to non-compliance with GxP;
Applies critical thinking to identify solutions to non-standard requests and complex problems;
Well versed in personnel management, customer management and project management;
Interacts with regulators, customers, and other external stakeholders on quality related matters.
Supervises a team.
What we’re looking for
Requires a Bachelor’s degree in a science/health care field or equivalent with significant experience and expertise in all aspects of GxP quality assurance auditing;
Previous experience in the conduct of multiple audit types (e.g. vendors, investigator sites, trial master files, data management, safety reporting, and laboratories) is essential;
Previous experience in a similar role is required;
Excellent knowledge of GxP regulatory requirements;