GCP Compliance Lead
BioMarin Pharmaceutical Inc.
full-time
Posted on:
Location Type: Remote
Location: United States
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Job Level
Tech Stack
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GCP ComplianceGood Clinical PracticesQuality Management SystemHealth Authority InspectionsR&D AuditsGCP Audit ProgramRegulatory ComplianceStrategic PlanningBudget MonitoringClinical Development
Soft Skills
LeadershipStrategic ThinkingAgilityPrioritizationCommunicationDecision MakingMentoringTeamworkCollaborationTrust Building