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 collaborate with program leaders, study teams and other SME to support the clinical development, provide quality consultancy, set up the quality plan, ensure its execution and provide the Sponsor quality oversight.
• 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 and mitigate quality and compliance issues and risks systematically and promote lessons-learned.
• You plan, prepare, conduct – remotely and on site – report and follow up GCP audits (includes Investigational Sites, CROs and supplier audits).
• Ideally, you perform GLP and/or GVP audits, 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 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 audit outcomes and define mitigation, you collaborate on inspections, agree and review quality metrics

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/or GVP regulations and guidelines
• You have supported clinical teams by bringing in your quality expertise, providing quality consultancy and you are able to develop strategies to resolve quality and compliance issues.
• You are an experienced senior GCP auditor and ideally GLP and/or GVP auditor, 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, 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