Associate Director, GVP Compliance

🕒 Junho 5

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BioMarin Pharmaceutical Inc.

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 1997

🧬 Biotecnologia

💊 Farmacêutico

💰 Post-IPO Debt em 2020-05

Biotechnology • Pharmaceuticals

BioMarin Pharmaceutical Inc. é uma empresa global líder em biotecnologia, dedicada a transformar descobertas genéticas em medicamentos inovadores. Fundada em 1997, a companhia desenvolveu oito produtos já comercializados que tratam doenças genéticas e doenças de depósito lisossômico potencialmente fatais, como acondroplasia e hemofilia A grave. A BioMarin também investe fortemente em pesquisa e desenvolvimento, com um pipeline robusto de medicamentos em investigação em diferentes fases de ensaios clínicos. A missão da empresa é aprimorar o cuidado ao paciente, aproveitando sua expertise científica para compreender as causas subjacentes dessas condições. A BioMarin é comprometida com a inclusão e a defesa dos pacientes, engajando-se de perto com as comunidades para elevar o nível de cuidado e a qualidade de vida das pessoas com condições raras.

Descrição

• Advancing the execution of the 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 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 • Execute against GVP Compliance processes and best practices • Perform GVP audits and contribute to the effective implementation of the Global GVP Audit Program • Act as a GVP compliance core team member on regulatory inspection teams and support mock readiness activities • Provide insights to continually optimize the GVP Compliance Audit Program • Contribute to Pharmacovigilance System Master File (PSMF) updates • Contributor to the Risk Evaluation and Mitigation Strategies (REMS) compliance program • Contribute to building a team that ensures GVP compliance and foster a culture of teamwork and mutual respect • Mentor and support the development of junior staff to achieve their full potential

🎯 Requisitos

• 8+ years of experience working within a regulated healthcare industry including a role in capacity of quality and compliance • Working knowledge of FDA, EMA, and global PV Regulations, and application of Good Pharmacovigilance Practices (GVP), ICH and GCP regulations • Experience working in Pharmacovigilance (PV) within Quality and Compliance • Experience executing or managing Health Authority Inspections • Experience executing or managing R&D Audits and GVP Audit Program • Experience with identifying optimal strategy for executing a GVP audit program working with internal auditors and external consultants • Experience navigating and understanding a quality management system • Core 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.

🏖️ Benefícios

• Equal Opportunity Employer/Veterans/Disabled