Company Description Medicine moves forward here.

Company Description Medicine moves forward here. Clinical trials, safety studies, and audits make safe and innovative pharmaceutical?Across the Group, our teams turn the signals that clinical trials, safety systems and quality data generate into insight that helps bring safer treatments to patients around the world.And this is where we excel. Whether you are early in your career or bringing decades of experience, we want you to feel valued for what you do and for who you are.

The Senior Auditor, Quality Assurance role is a senior role that effectively manages and conducts internal and contracted audits for the Company and for Company's Clients. The role provides input into audit strategy and risk-based audit planning and leads process and complex audits, as well as providing QA consultancy activities within their area of GxP expertise.Core Responsibilities Of The Senior Auditor Are AuditingWithin area of their GxP expertise, conduct audits initiated by the Company, or contracted by small to mid-size Clients, according to the agreed Audit Program including effective management of pre-audit activities.Audit Types May Include Audits of Company Partners and Vendors/Service ProvidersInternal System AuditsStudy audits (e.G. of study files, investigational sites)Audits of Third Parties on behalf of Clients (e.G. including MAH PV System, Vendors, MAH Affiliate/ Partner Audits). Reviews and approves all final CAPA plans from contracted audits within timelines mandated by Company/ Client proceduresConsultancies e.Client PV / QMS system gap analysis, SOP development, etc.Main QA contact for designated Clients and plans, conducts and reports on audits requested by ClientsQuality as a Service Attend commercial meetings related to Quality as a ServiceSupports Clients with a wide variety of Quality as a Service activities,



including Mock inspectionsTrainingGap analysisProcedure drafting and revisionOther Supports audits and inspections of the Company performed by Clients/third parties and regulatory authoritiesWorks with the Quality leadership to develop and train Auditors and other quality employeesAssists in the development of strategic internal audit programMaintain an up-to-date knowledge of international regulatory requirements, guidelines and best practices and actively participate in knowledge-sharing and learning process to ensure personal and team continuous learning and developmentParticipate in preparation (authoring or QC) of audit strategy, SOPs, guidelines and other documented procedures required for auditing activity of the Company and/or Client as per operational needsQualifications Bachelor's degree in a scientific discipline required; Master's degree preferred, or equivalent relevant industry experience.Experience Strong previous pharmaceutical and/or biotech pharmacovigilance experience, including strong understanding of GVP & GCP related Quality Management and Assurance, with previous experience of GVP and GCP auditing experience in an Audit Lead role.Analytical, written and oral communication skillsAbility to manage all tasks assigned and effectively deliver all expected deliverables in an organized and a timely mannerProactively communicate changes in pre-established goals and deadlinesAbility to think strategically and to work collaboratively using risk-based, proactive approaches to problem-solvingStrong team playerFluent in English (written and spoken); additional/ local languages a plus, but not requiredAdditional Information When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world.

You'll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.Quality: we hold ourselves to the standard patients deserve.

📌 Senior QA Auditor (Madrid)
🏢 Ergomed
📍 Madrid