GCP Compliance Lead

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BioMarin Pharmaceutical Inc.

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1001 - 5000 employés

Fondée en 1997

🧬 Biotechnologie

💊 Pharmaceutique

💰 Post-IPO Debt en 2020-05

Biotechnology • Pharmaceuticals

BioMarin Pharmaceutical Inc. est une entreprise de biotechnologie mondiale de premier plan, dédiée à transformer les découvertes génétiques en médicaments innovants. Fondée en 1997, l'entreprise a développé huit produits commercialisés qui traitent des maladies génétiques et des troubles du stockage lysosomal mettant en jeu le pronostic vital, tels que l'achondroplasie et l'hémophilie A sévère. BioMarin investit fortement dans la recherche et le développement, avec un pipeline robuste de médicaments expérimentaux à divers stades d'essais cliniques. La mission de l'entreprise tourne autour de l'amélioration des soins aux patients en utilisant une expertise scientifique pour comprendre les causes sous-jacentes de ces conditions. BioMarin s'engage à l'inclusivité et à la défense des patients, en travaillant étroitement avec les communautés pour améliorer les soins et la qualité de vie des personnes atteintes de maladies rares.

Description

• Championing the implementation of Global Quality vision, policies, processes, and decisions • Collaborate with stakeholders to identify, communicate, and mitigate compliance risks • Continually enhance partnerships with key stakeholders and leaders as a trusted advisor across the business • Support and drive the implementation of quality and compliance projects and objectives • Stay updated on regulations and recommend proactive compliance changes when necessary • Develop and enhance GCP Compliance processes and best practices • Maintain BioMarin processes to ensure evaluation & escalation of serious non-compliance • Lead the execution of the GCP Compliance Global Audit Program • Act as a GCP compliance core team member on regulatory inspection teams and support mock readiness activities • Provide insights to continually optimize the GCP Compliance Audit Program • Create a high-functioning team to ensure GCP compliance and foster a culture of teamwork and mutual respect • Mentor and develop staff to achieve their full potential • Conduct management activities, including staffing, budget monitoring, and strategic planning • Manage recruiting, hiring, and evaluations with HR and Global Quality leadership

🎯 Exigences

• 10+ years of experience working within a regulated healthcare industry including a role in capacity of quality and compliance • Working knowledge of FDA, EMA, PMDA and global PV Regulations, and application of Good Clinical Practices (GCP), ICH and GCP regulations • Experience working in Clinical Development within Quality and Compliance • Experience executing or managing Health Authority Inspections • Experience executing or managing R&D Audits and GCP Audit Program • Experience with identifying optimal strategy for executing a GCP audit program working with internal auditors and external consultants • Experience navigating and understanding a quality management system • Core leadership competencies in strategic thinking, agility, prioritization, communication and decision making • Strong verbal, written and oral communication skills. Able to present to Senior Leadership. • Strong computer skills including working within the MS Suite of tools, and interfacing with Quality Management Systems

🏖️ Avantages

• Flexible work arrangements • Professional development opportunities