.Job DescriptionThe PositionThe Senior Specialist, Quality Assurance Auditor, ensures quality and compliance with local and international regulatory requirements by conducting internal and external audits. This role provides guidance to internal stakeholders, assisting in the establishment of the company's compliance strategy and the resolution and prevention of compliance risks.Responsibilities:Evaluate Organon systems, processes, Affiliates, Vendors, Business Partners, and Investigator sites for compliance with regulatory requirements.Schedule and conduct GVP/GCP audits in accordance with the global audit plan ensuring compliance with local and international guidelines and regulations.Prepare audit reports and manage follow-up activities with limited guidance.Conduct meetings with Senior Management to discuss audit observations and responses.Supports the implementation and maintenance of the GVP/GCP risk-based strategy, including development of the annual audit plan.Responsible to ensure audit tracking tools are up to date.Participate in regulatory inspections and external audits, when required.Review and provide input into the quality sections of the Pharmacovigilance System Master File (PSMF).Maintain a high degree of knowledge of global industry expectations and GVP/GCP regulations.Train and mentor junior team members.Required Education, Experience, and SkillsBachelor's degree in a relevant field (Pharmacy, Life Sciences, etc.).Minimum of five (5) years of experience in the pharmaceutical industryMinimum of one (1) years of experience in GVP/GVP auditing with EU/FDA /global regulatory requirementsStrong knowledge of EMA, FDA and ICH guidelines.Attention to detail and ability to work independently.Proficiency in Microsoft applications (Word, Excel, PowerPoint, Outlook).Preferred Education, Experience, and SkillsFluency in written and spoken English, additional language skills a plus.Primary skills include but are not limited to:Collaboration and Partnering : Demonstrates ability to work in partnership with others within the Company and external partners to accomplish quality goals; possesses advanced leadership skills.Communication Skills: Strong verbal skills and experienced effective writing skills.Project Management: Demonstrates ability to organize work efforts, prioritization of tasks and utilize appropriate resources to deliver or support work products in accordance with timelines and appropriate regulations.Decision Making: Demonstrates skills to utilize knowledge, networks, and data to make rapid and appropriate decisions and to determine when escalation of issues is necessary.Business Operations/Knowledge of Field: Demonstrates knowledge of regulations. Regulatory and business trends and applies this knowledge to optimize daily activities and ensure the functional areas within R&D are compliant with regulations and appropriate procedures
