Clinical Quality Manager (f/m/d)

Our people in Manufacturing & Global Operations share two priorities: getting things done and making things better. If you’re a dynamic person with a positive mindset, you’ll fit in well here. It’s an international team with a powerful spirit of collaboration. Together, we make sure our products meet the highest standards of quality by constantly searching for ways to improve at every stage of our value chain – from the raw materials we buy through to the logistics network that brings our medicines to patients. Join our team and help us make an even bigger contribution to Grünenthal’s future.

What the job looks like
Each day you´ll enjoy a variety of challenges, such as:

• 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 pharmacovigilance annual audit program, too
• You manage audits of high complexity and/or criticality, summarize complex outcomes in an executive form 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 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 identify and mitigate quality and compliance issues and risks systematically and promote lessons-learned

What you´ll bring to the table

To make the most of this role and truly thrive, you should have:

• 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)
• You know in depth GCP and ideally GLP and GVP regulations and guidelines
• You are an experienced senior auditor in the clinical and ideally in the preclinical and pharmacovigilance area with audits 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.

• You are structed, result oriented and performance driven, show strong problem solving, decision making, 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 and you have the willingness to travel worldwide.

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"Quality from the beginning. In this function you play an important role in ensuring that our Research & Development Partners deliver according to the applicable standards and improve every day." Kuth Astrid, the Hiring Manager