Description

Principal Auditor - *GCP experience requiredSyneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring together talented experts across a broad spectrum of business critical corporate functions. Every role plays an essential part in enabling our customers to achieve their goals. Our teams are agile, collaborative, and committed to delivering—for each other, for our customers, and ultimately for the people who rely on the services we support. Discover what your 25,000 future colleagues already know: 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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities*Please apply for this role with a CV in English. Job Summary Conduct audits to assess compliance with applicable regulations, company policies, standard operating procedures and (SOPs) work instructions (WI), contracts and project-specific requirements. Hosts and supports customer audits and regulatory inspections in accordance with QA SOPs and WIs. The Principal Quality Assurance (QA) Auditor is a seasoned professional who has significant expertise in GxP requirements and extensive experience in the conduct of various audit types. This role is therefore also responsible for other QA program initiatives such as mentoring of QA staff, training of operational staff, development and review of QA and regulatory standards and external engagement.<div><h2>General Profile</h2><ul><li>Syneos Health Audits<ul><li>Plans and conducts assigned audits.</li><li>Performs For Cause audits as needed.</li><li>Writes and issues audit reports, ensuring clear communication of audit findings to the auditees and relevant management.</li><li>Reviews responses to audit findings for appropriateness and completeness.</li><li>Closes assigned audits.</li></ul></li><li>Customer Audits/Inspections<ul><li>Prepares for and hosts or supports customer audits.</li><li>Prepares for and hosts or supports Regulatory Authority Inspections.</li></ul></li><li>Other<ul><li>Serves as Lead Auditor on team-based Syneos Health audits.</li><li>Serves as a trainer and mentor to less experienced QA Auditors.</li><li>Provides guidance and training to operational staff on quality related matters.</li><li>Writes, reviews or revises QA SOPs/WIs</li></ul></li></ul></div><div>Complexity<ul><li>Applies critical thinking to identify solutions to non-standard requests and complex problems.</li></ul></div><div>Supervision<ul><li>Requires minimal instructions on day-to-day work and new assignments.</li></ul></div><div>Other tasks<ul><li>May review audit reports of peers.</li><li>May provide coaching and training to company personnel on quality-related matters.</li><li>Participates in local and / or company-wide special projects according to his / her skills or talents and the needs of the organization.</li><li>Involves himself / herself in appropriate industry associations and other relevant forums.</li></ul></div><h2>Requirements</h2><ul><li>A minimum 5 years experience within GCP (Phase I-IV Clinical Trials) required</li><li>Requires a Bachelor’s degree in the science/health care field or equivalent with significant experience and expertise in various aspects of GxP quality assurance auditing.</li><li>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.</li><li>Knowledge of Medical and technical terminology related to the audit types to be conducted.</li><li>Computer literacy commensurate with job requirements (Microsoft Office suite; basic Sharepoint proficiency).</li><li>Able to handle multiple tasks to meet timelines in dynamic environment.</li></ul>Get to know Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. <a href="http://www.syneoshealth.com" target="_blank">http://www.syneoshealth.com</a>Additional InformationTasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.