Dear Sir or Madam, For a pharmaceutical project, I am currently looking for an R&D Quality Manager / Senior Auditor (m/f/d). Project details: Start: ASAP Duration: 6 months, with the option of permanent employment Workload: Full-time Location: Frankfurt am Main, with 2 - 3 days of remote work per week Contract type: Employee leasing (Arbeitnehmer ü berlassung) This role is responsible for quality oversight and support for clinical development projects and Ax R&D Quality Management System. This includes an independent review of the planning, conduct, reporting and documentation of clinical activities and the computer systems used, on the basis of the relevant medical device and pharmaceutical legislation regulations, internal and external standards and guidelines. Responsibilities: Audit Programs: Planning and performance of various Clinical medical devices & medicinal products project audits (e.g. Investigator Site audits, process audits, TMF audits, CSP/CSR audits) against GxP and local regulatory requirements Creating audit plans for the studies based on risk assessments/analyses Planning and performance of internal process and vendor audits Quality Issue Management: To lead the evaluation and management of clinical site-specific escalations related to persistent or serious misconduct Quality Management System: Collaboration in the further development and maintenance of the Quality Management System (R&D relevant parts), e.g. document management, CAPA, deviation and SOP System Assistance in the development of Company Standard Operating Procedures Collaboration on quality metrics for reporting to leadership Quality Consultation & Project-Specific Support: QA Business Partner for Clinical Operation team to overview and support relevant ClinOps sub-divisions on CAPAs management Provide independent consultation with focus on clinical activities in collaboration with project teams Provide consultation for quality-related and GCP-related inquiries for clinical activities in Ax R&D Supplier Qualification: Provide support of qualification process of suppliers relevant for clinical development Planning and performance of various clinical vendors audits (CRO, warehouses for clinical supplies, clinical laboratories central/safety labs & specialized labs), couriers, archiving services etc) against GxP and local regulatory requirements Training: Contribution to training for selected functional groups related to Good Clinical Practice, Good Clinical Laboratory Practice, Good Pharmacovigilance Practice (pre-marketing related), clinical trials regulations Regulatory Authority Inspections: Hosting the local and international Notified Body and authorities ' inspection / External Audits CAPA management of the RA inspections / External Audits Supporting inspection readiness / regulatory compliance status at R&D Technical & Functional Skills: Fluent English (written and verbal) is mandatory Comprehensive knowledge of the regulations and standards for conducting clinical trials in the field of medical devices or comprehensive knowledge of the regulations for conducting clinical trials in the field of medicinal products Comprehensive knowledge in the execution of audits in the "GCP" area (medical device products: ISO 14155 or pharmaceutical: ICH-GCP "E6") Knowledge of Microsoft Office Suite including Excel, Word, PowerPoint, WebEx/Teams and SharePoint Management and facilitation of audits/inspections (incl. GCP audits of any type, sponsor inspections Minimum Qualifications: Bachelor ' s Degree in natural science, pharmacy or medicine 10 years of professional experience in the field of clinical quality assurance oversight and/or management 5 years of professional experience as a QA Auditor and executing a QA Manager role in pharmaceutical/medical device industry Preferred Qualifications: Master ' s Degree in natural science, pharmacy or medicine Prior experience developing risk-based quality management programs across clinical development preferred Experience working and communicating within cross-functional teams Knowledge of overall clinical trial management process, understanding of the protocol and other clinical trial related plans and documents Critical thinking and analytical skills to understand and analyze complex data and provide insight into risk report, trends, and outliers in data If you are interested, please send me your current CV, including your earliest possible start date and desired gross annual salary, as well as your references. I will get back to you after reviewing your application. If you are not interested or currently unavailable but know someone who might be a good fit for this position, please let us know. We reward every successful referral with a €250 Amazon voucher! I look forward to your response and thank you in advance. Kind regards, Mariam Gareginyan Asscoiate Principal Candidate Consultant E-Mail: m.gareginyan(@)sthree.com SThree_Germany is acting as an Employment Business in relation to this vacancy.