Associate Director, GVP Compliance

🕒 June 5

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BioMarin Pharmaceutical Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

🧬 Biotechnology

💊 Pharmaceuticals

💰 Post-IPO Debt on 2020-05

Biotechnology • Pharmaceuticals

BioMarin Pharmaceutical Inc. is a leading global biotechnology company dedicated to transforming genetic discoveries into innovative medicines. Founded in 1997, the company has developed eight marketed products that address life-threatening genetic and lysosomal storage disorders such as achondroplasia and severe hemophilia A. BioMarin is also heavily invested in research and development, with a robust pipeline of investigational medicines at various clinical trial stages. The company's mission revolves around improving patient care by leveraging scientific expertise to understand the underlying causes of these conditions. BioMarin is committed to inclusivity and patient advocacy, engaging closely with communities to enhance care and quality of life for those with rare conditions.

📋 Description

• 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

🎯 Requirements

• 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.

🏖️ Benefits

• Equal Opportunity Employer/Veterans/Disabled