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Ascendis Pharma, a global biopharmaceutical company, is seeking a Senior PV Quality Manager to join its expanding GVP Quality team in Hellerup, Denmark. This role is part of the QA Development team (approximately 35 colleagues across Hellerup and Palo Alto) and reports directly to the Director of GVP Quality.
You will oversee and manage compliance, quality standards, GVP auditing, and training for Pharmacovigilance. Key responsibilities include planning and executing GVP audits (internal, affiliate, and vendor/partner), reviewing audit and inspection data to identify trends and root causes, preparing compliance metrics, and conducting non-compliance investigations. You will provide expert guidance on GVP compliance and regulatory matters to PV Operations and the EU QPPV, author and maintain GVP Quality procedures, support implementation of new GVP requirements, and oversee PV vendor qualification and quality agreements.
You will collaborate with subject matter experts on inspection responses and quality development initiatives, acting as a global quality partner across the organization. The role requires strong decision-making ability, a quality mindset, and meticulous attention to detail in prioritization and deadline management.
Required qualifications: degree in a scientific discipline, 5–10 years of pharmaceutical industry experience with significant GVP background, expertise in quality systems and compliance monitoring, and experience developing and maintaining SOPs and training programs. Prior GVP auditing experience is advantageous but not required. Proficiency in English (written and spoken) and MS Office is essential. Experience auditing computerized systems in GVP-regulated areas and medical devices is a plus.
You are a highly motivated, collaborative individual with excellent interpersonal, communication, analytical, and organizational skills. The position involves approximately 20–30 days of travel annually. Ascendis offers an entrepreneurial, international environment with a flat organizational structure and involvement in strategy-central activities alongside skilled colleagues advancing an exciting product pipeline.
