Senior QA Auditor (m/f/d) - Clinical Trials || BAWÜ || Medical Devices Responsibilities:Lead audits for clinical trials and medical products to ensure compliance with GxP and regulatory standards.Develop and implement audit plans based on risk assessments and conduct internal process and vendor audits.Address and escalate serious clinical trial violations, ensuring timely resolution.Contribute to the development and maintenance of the Quality Management System (QMS), focusing on document management, CAPA, deviations, and SOPs.Advise the Clinical Operations team on CAPA management and quality-related issues.Provide independent consultation on GCP-related and quality issues within clinical research.Support the qualification process for clinical development suppliers and lead supplier audits.Train employees on best practices in GCP, GCLP, pharmacovigilance, and clinical trial regulations.Coordinate inspections and audits by regulatory authorities and ensure readiness for external audits.Manage CAPA actions from inspections and support regulatory compliance within R&DRequirements:Master's degree in Natural Sciences, Pharmacy, Medicine, or a related field.At least 8 years of experience as a QA Auditor, preferably in clinical research or the medical device industry.Strong knowledge of GxP guidelines, clinical trial processes, and relevant regulatory standards.Experience conducting audits, inspections, and managing compliance.Excellent analytical skills, with the ability to assess complex data and identify risks and trends.Independent, organized, and able to work effectively with cross-functional teams.Strong communication skills and the ability to collaborate internationally.Willingness to travel (approx. 20% of the time).Fluency in English; German is a plus.Proficiency in Microsoft Office, especially Excel and PowerPoint.About the Client: This company offers a great working environment with a global perspective and the opportunity to work in an international team. The flexible hybrid model allows you to work 2 days in the office and 3 days remotely. With an average employee tenure of over 8 years, the company provides long-term stability and growth opportunities. In addition to a competitive salary, employees enjoy attractive benefits such as Wellpass, Jobticket, Jobbike, 39 vacation days, a pension plan, and childcare support.If you're passionate about driving clinical trials forward in the field of medical devices, with a strong emphasis on cross-functional leadership, efficiency, and quality compliance, we encourage you to apply.I´m looking forward to seeing your application! Contact details:E-Mail: M.Inderhees@sciproglobal.deTel: 089 26 20 09 25

SciPro are once again collaborating with one of our small, rare disease pharmaceutical partners who are pioneering a new formulation of their rare disease therapy. An exciting time for the company, they are expanding their Clinical Operations team in the UK. We are leading their search for an experienced TMF/CTMS Manager to oversee and optimize our electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS). This role ensures compliance, enhances Sponsor oversight, and supports risk-based monitoring strategies.Key Responsibilities:Manage and optimize Veeva eTMF and CTMS for clinical trial execution.Ensure compliance with ICH E6(R3), GCP, and regulatory standards.Train and support teams on eTMF/CTMS best practices.Key Requirements:5+ years of clinical trial documentation/management experience.Expertise in Veeva eTMF and CTMS implementation.Knowledge of global regulatory requirements (FDA, EMA, MHRA).