pMedicine moves forward here. So will you. /ppClinical trials, safety studies, and audits make safe and innovative pharmaceutical-led care possible. As part of Ergomed Group, you help patients vantaggi so they experience more of life's meaningful moments. Biopharmaceutical companies are our clients. Patients are our purpose. /ppErgomed Group brings together Ergomed CRO, PrimeVigilance, Prudentia, and ADAMAS Consulting to help biopharmaceutical companies develop, deliver and safeguard therapies in oncology, rare disease and other complex areas of medicine. 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. /ppThe science and analysis that guides our work is demanding. And this is where we excel. What defines us, though, is how we work together. Across countries, cultures and time zones, we bring kindness, curiosity and a shared sense of purpose to work that genuinely matters. Ideas are welcome here. Growth is expected. And every person has room to make a real difference to patients' lives. /ppWhether 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. If that sounds like the place you have been looking for, we would love to hear from you. /ph3Job Description /h3pbJob Description /b /ppThe 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. /ppCore responsibilities of the Senior Auditor are: /pulliAuditing /liliWithin 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.



/li /ulpAudit types may include: /pulliAudits of Company Partners and Vendors/Service Providers /liliInternal System Audits /liliStudy audits (e.g. of study files, investigational sites) /liliAudits of Third Parties on behalf of Clients (e.g. including MAH PV System, Vendors, MAH Affiliate/ Partner Audits).ulliReviews and approves all final CAPA plans from contracted audits within timelines mandated by Company/ Client procedures /li /ul /liliMain QA contact for designated Clients and plans, conducts and reports on audits requested by Clients /liliQuality as a ServiceulliAttend commercial meetings related to Quality as a Service /liliSupports Clients with a wide variety of Quality as a Service activities, includingulliMock inspections /liliTraining /liliGap analysis /liliProcedure drafting and revision /li /ul /li /ul /liliOtherulliSupports audits and inspections of the Company performed by Clients/third parties and regulatory authorities /liliWorks with the Quality leadership to develop and train Auditors and other quality employees /liliAssists in the development of strategic internal audit program /liliMaintain 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 development /liliParticipate 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 needs /li /ul /li /ulh3Qualifications /h3ulliBachelor’s degree in a scientific discipline required; Master’s degree preferred,



or equivalent relevant industry experience. /li /ulpbExperience /b /pulliStrong 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. /liliAnalytical, written and oral communication skills /liliAbility to manage all tasks assigned and effectively deliver all expected deliverables in an organized and a timely manner /liliProactively communicate changes in pre-established goals and deadlines /liliAbility to think strategically and to work collaboratively using risk-based, proactive approaches to problem-solving /liliStrong team player /liliFluent in English (written and spoken); additional/ local languages a plus, but not required /li /ulh3Additional Information /h3pWhen 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. /ppWe are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here. /ppQuality: we hold ourselves to the standard patients deserve. /ppIntegrity and trust: we do the right thing, especially when it is hard. /ppDrive and passion: we care about the outcome, because someone is waiting on it. /ppAgility and responsiveness: we move quickly, because patients cannot wait. /ppBelonging: everyone is welcome, and every voice counts. /ppCollaborative partnerships: we go further by going together. /ppWe look forward to welcoming your application. /ppBy clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy apply /p #J-18808-Ljbffr

📌 Senior Auditor, Quality Assurance (Roma)
🏢 Ergomed Group
📍 Roma