GCP Compliance Lead

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🕒 April 16

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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

• 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

🎯 Requirements

• 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

🏖️ Benefits

• Flexible work arrangements • Professional development opportunities