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

BioMarin Pharmaceutical Inc. (Swiss Office) seeks a Senior Manager for R&D Quality, focusing on document control and training within a GxP-regulated environment.

This position leads the controlled document and training processes for the Technical Operations group, which develops drugs for clinical trials and commercial production. The role ensures compliance and operational effectiveness within a GxP-regulated setting.

Responsibilities

• Manage and oversee controlled document and training workflows in a GxP-regulated environment.
• Identify and implement process improvements across document control, training, and quality systems.
• Prepare for and support internal and external audits and inspections.
• Track quality system metrics to spot trends and areas for enhancement.
• Collaborate with cross-functional teams to boost compliance, standardization, and operational efficiency.
• Serve as a subject matter expert for document control and training systems.

Requirements

• Proven background in Quality, Quality Systems, or Compliance within biotech, pharma, or life sciences.
• Extensive experience managing document control and training processes in regulated settings.
• Solid understanding of GxP requirements applicable to R&D and development organizations.
• Ability to influence stakeholders and work effectively in a matrixed, cross-functional environment.
• Track record of supporting inspections, audits, and continuous improvement projects.

Nice to have

• Hands-on experience with Veeva Vault.
• Hands-on experience with ComplianceWire.
• Background in R&D, clinical, nonclinical, or development-phase quality environments.
• Experience with metrics, reporting, and process harmonization.

What the company offers

• Eligibility for a discretionary annual bonus.
• Eligibility for discretionary stock-based long-term incentives.
• Paid time off.
• Company-sponsored medical, dental, vision, and life insurance plans.

About the company

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. The company is guided by a purpose to develop medicines that make a profound impact on people’s lives, driven by a dedicated team of industry experts working together.

• Unwavering commitment to excellence.
• Deep understanding of patient needs.
• Scientific expertise and world-class manufacturing capabilities.
• Collaborative team of the brightest minds in the industry.