.DescriptionSenior Auditor, Quality AssuranceSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job responsibilities Syneos Health Audits Plans and conducts assigned audits.Performs For Cause auditsWrites and issues audit reports, ensuring clear communication of audit findings to the auditees and relevant management.Reviews responses to audit findings for appropriateness and completeness.Closes assigned audits.Prepares for and hosts or supports customer audits.Prepares for and hosts or supports Regulatory Authority Inspections.Serves as Lead Auditor on team-based Syneos Health audits.Serves as Assisting Auditor on team-based Syneos Health audits.Serves as a trainer and mentor to less experienced QA auditors.Requires minimal instructions on day-to-day work and new assignments.May write, review or revise QA Standard Operating Procedures (SOPs) / Work Instructions (WIs).Performs other work-related duties as assigned.Moderate travel may be required (up to 50%). QualificationsWhat we're looking for Requires a Bachelor's degree in the science/health care field or equivalent with 5 years experience in GxP quality assurance auditing in the Pharma or CRO sector.Previous experience in the conduct of multiple audit types (e.G. vendors, process, computer system validation).Previous experience in supporting customer audits or regulatory inspections is a plus
