Ihre Aufgaben:

You plan, prepare, conduct – remotely and on site – report and follow up audits from the clinical annual audit program (includes Investigator Site, Contract Research Organisation and external supplier audits). Ideally, you perform audits from the pre-clinical and/or pharmaco-vigilance annual audit program, too
You manage audits of high complexity and/or criticality at external supplier/partner sites, summarize complex outcomes of audits in an executive form and develop and present actions to improve quality, compliance and performance
You ensure that audits comply with the principles of GCP, GLP or GVP, respectively, and are undertaken in line with applicable regulatory requirements and organizational priorities and standards.
You contribute to the strategic development of an risk-based clinical and pre-clinical annual audit program and supplier quality management program, designed to improve their standards and compliance status and promote Quality Culture
You collaborate with program leaders and other SME to support the clinical development, you set up the quality plan and ensure its execution and provide the Sponsor quality oversight
You build and manage a strong relationship to suppliers (CROs) by defining the quality governance. With the CRO you align the quality and audit-related strategy and planning, you share subcontractor and Investigator Site audit outcome and define mitigation, you collaborate on inspections, agree and review quality metrics
You implement the strategy and execute the audit program for clinical trials (includes IS, CROs and clinical suppliers), and manage the CAPAs
You identify, manage, evaluate and mitigate complex quality and compliance issues and risk systematically and promote lessons-learned
You set up, negotiate and maintain Quality Agreements

Ihre Qualifikationen:

You have a MSc in Natural Science, Pharmacy, you are a Medical Doctor, or have a comparable degree or adequate education
You have in depth knowledge and extensive experience throughout all stages of clinical development and clinical trial conduct in a pharmaceutical environment
You have deep knowledge and understanding of applicable GCP and ideally GLP and GVP regulations and guidelines
You have experience in successfully auditing different types of suppliers and service providers in the clinical and ideally in the preclinical and/or pharmacovigilance area, such audits presenting different level of risks and complexity and were conducted in multiple cultural areas
You are able to assess IT Service Providers to verify compliance with applicable regulations and assuring data integrity Ideally you have experience and knowledge in Project Management and OPEx tools and methods
You have advanced communication and negotiation skills and are able to manage, influence and collaborate with suppliers and stakeholders in a highly outsourced and highly matrixed model
You are structed, result oriented and performance driven and show strong problem solving, decision making and improvement and performance-oriented mindset, applying the adequate tools
You have fluent business English language skills in speaking and writing
You are willing to travel worldwide

Ihre Vorteile:

International Company

Clinical QA Manager - Auditor (m/f/d)