Senior Auditor, Clinical Quality and Compliance, Germany

<h3>Description</h3> <p>The role of the Sr. Auditor, Clinical Quality and Compliance is to act as lead person in the establishing audit plans, assessing/securing compliance in study conduct and to provide strong support to operations via GxP consultation.</p><p><br/></p><p><strong>This role will be perfect for you if</strong>:</p><ul><li>You approach challenges with an understanding of norms and regulations, combined with a creative and inquisitive mind</li><li>You enjoy working with a small team, contributing your experience and expertise to complete a variety of tasks , including special projects</li><li>You love being a mentor in different types of audits</li></ul><p><br/></p><p><strong>RESPONSABILITIES</strong></p><p>More specifically, the role of Sr Auditor, Clinical Quality and Compliance includes:</p><ul><li>Implement robust audits plan and execute audits in accordance with the established audit program.</li><li>Act as a lead/mentor for the conduct of audit activities (site, studies, internal and vendors). Performs review of audit of reports issued by the auditors.</li><li>Coordinate and conduct clinical sites audit with the project management team. Where applicable, facilitate the audit with the external auditors.</li><li>Participate in the auditor’s training in providing guidance on audit techniques, risk assessment and system approach.</li><li>Formulate observation/recommendations and review appropriateness of audit responses/CAPA plan and track progress.</li><li>Review and assess non-compliances, adequacy of CAPA plan and track the progress of action items. Lead thorough and complete investigations where needed.</li><li>Provide solid recommendation/guidance via GxP consultation and support auditor in their consultation as needed.</li><li>Organize and hosts sponsor’s study audits and regulatory inspections including mock inspection activities.</li><li>Work closely with the Quality Systems group for internal, vendor audits and periodic risk review of vendors. Can also be involved in client’s qualification audits and review of SOPs.</li><li>Develop training content for topics related to SOP, regulations and GxP. Can provide training to Innovaderm employees.</li><li>Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.</li></ul><p><br/></p><p><br/></p><p><br/></p> <h3>Requirements</h3> <p><strong>Education</strong></p><ul><li>Bachelor degree in a relevant discipline or equivalent experience;</li></ul><p><br/></p><p><strong>Experience</strong></p><ul><li>5-10 years’ experience in the pharmaceutical or research industry (more specifically in clinical quality)</li></ul><p><br/></p><p><br/></p><p><strong>Knowledge and skills</strong></p><ul><li>Excellent knowledge of ICH guidelines, FDA and local regulatory requirements and EU standards and regulations, Health Canada regulations</li><li>Master the overall audit process and risk determination</li><li>Ability to communicate effectively both orally and in writing</li><li>Good organization skill and ability to adapt to a rapidly growing environment</li><li>Fluency in German, Polish and English is an asset.</li><li>Proficiency in additional languages is considered a valuable asset</li><li>Good knowledge of the Microsoft Office Suite (Word, Excel, PowerPoint)</li><li>Willing to travel 10-30% of the time</li></ul> <h3>Our company</h3> <p><strong>The work environment</strong></p><p><strong> </strong></p><p><strong>At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. </strong></p><p><strong> </strong></p><p><strong>Recruitment process: what to expect </strong></p><ul><li>As part of the recruitment process for this position you will meet various team members at Indero</li><li>The first interview will be conducted by Teams (30 minutes) and the second via video conference (1 hour)</li></ul><p><br/></p><p><strong>About Indero </strong> </p><p><br/></p><p>A Global Clinical Leader In<strong> Dermatology!</strong></p><p><br/></p><p><strong>Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.</strong></p><p><br/></p><p><strong>Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and