Clinical QA Manager - Auditor

If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In Research & Development, we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve. You’ll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the live of patients for the better and help us make progress towards our vision of a world free of pain. Join us today, and discover the difference you can make.

What the job looks like:

• You collaborate with program leaders, study teams and other SME to support the clinical development, you provide quality consultancy, set up the quality plan and ensure its execution and provide the Sponsor quality oversight for a dedicated development program or trial;
• You develop and implement a quality strategy to support the compliant execution of the clinical studies, e.g. by defining the auditing strategy and program (includes Investigational Sites, CROs and clinical suppliers);
• You identify, manage, evaluate and mitigate complex quality and compliance issues and risks systematically and promote lessons-learned;
• 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 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 set up, negotiate and maintain Quality Agreements.

What you'll bring to the table:

• 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 (e. g. as Quality Manager, CRA, Project manager of clinical trials, auditor, clinical scientist or data manager) in a pharmaceutical environment;
• You have deep knowledge and understanding of applicable GCP and ideally GLP and GVP regulations and guidelines;
• You have supported clinical teams by bringing in your quality expertise and providing quality consultancy and you are able to develop strategies to resolve quality and compliance issues;
• Proven track record over several years of 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 (infrastructure, (cloud) applications, cS Validations) 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, German language skills are beneficial;
• You are willing to travel worldwide.

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