Senior Manager, R&D Quality – Document Control & Training

Responsibilities

• Lead controlled document and training processes within a GxP-regulated environment
• Drive continuous process improvements across document control, training, and quality systems workflows
• Support audit and inspection readiness activities to ensure regulatory compliance
• Monitor and trend quality system metrics to identify opportunities for operational improvement
• Partner cross-functionally with Clinical, Regulatory, and Safety teams to improve standardization and effectiveness
• Provide subject matter expertise on document control and training systems

Requirements

• Experience in Quality, Quality Systems, or Compliance within the biotech, pharma, or life sciences industry
• Strong expertise in document control and training processes in a regulated environment
• Deep knowledge of GxP requirements relevant to R&D and development organizations
• Proven ability to work cross-functionally and influence stakeholders in a matrixed environment
• Experience supporting regulatory inspections and audits

Preferred Qualifications

• Direct experience using Veeva Vault
• Direct experience using ComplianceWire
• Experience working in R&D, clinical, nonclinical, or development-phase quality environments
• Experience with metrics, reporting, and process harmonization

About the Company

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams deliver revolutionary treatments for conditions such as achondroplasia, PKU, and various forms of MPS.