BioMarin Pharmaceutical Inc.
We transform lives through genetic discovery.
Director, GVP Compliance
Location
United States
Posted
97 days ago
Salary
Not specified
Seniority
Lead
Bachelor Degree10 yrs expEnglishGoogle Cloud Platform
Job 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 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 GVP Compliance processes and best practices
• Lead the execution of the GVP Compliance Global 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
• Core team member and key contributor to the Risk Evaluation and Mitigation Strategies (REMS) compliance program
• Create a high-functioning team to ensure GVP 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
Job 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, 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 leadership competencies in strategic thinking, agility, prioritization, communication and decision making
- Experience in managing staff and leading teams
- Strong verbal, written and oral communication skills. Able to present to Senior Leadership. Able to work independently and be flexible to rapidly changing priorities.
- Strong computer skills including working within the MS Suite of tools, and interfacing with Quality Management Systems
Benefits
- Health insurance
- Flexible working arrangements
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