Senior Auditor, Clinical Quality and Compliance, Poland

<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 Polish and English is required. </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>At Innovaderm, 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> </strong></p><p><br/></p><p><strong>In this position, you will be eligible for the following perks: </strong></p><ul><li>Permanent full-time position</li><li>Flexible schedule</li><li>Vacation</li><li>Home-based position</li><li>Ongoing learning and development</li></ul><p><br/></p><p><strong>Work location </strong></p><p><strong></strong></p><p><strong>The successful candidate for this position is given to work remotely anywhere in Poland.</strong></p><p><br/></p><p>Employees located outside of North America are expected to have some flexibility in their working hours to accommodate team or client meetings as needed. All efforts will be made by Innovaderm to accommodate various time zones of team members. <strong></strong></p><p><br/></p><p><strong>About Innovaderm</strong> </p><p>Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe. </p><p><br/></p><p> </p><p><strong><em>Innovaderm is committed to providing equitable treatment and equal opp