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

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

GCP Compliance Lead

Key skills